AUSTIN, TX– Oct. 19, 2011–Drummond Group Inc. (DGI), the trusted interoperability test lab, last week submitted to the DEA its e-Prescribing of Controlled Substances (ePCS) Certification Process documentation. The DEA is currently reviewing this ePCS Certification Process for approval. Upon approval, DGI will be providing ePCS certification to healthcare software companies with the capability of e-Prescribing controlled substances.
Since 2005, Drummond Group has been the lead auditor and certification organization for the DEA’s final rule regulations on the Controlled Substance Ordering System (CSOS). CSOS enables drug manufacturers, distributors and pharmacies to electronically automate the order and fulfillment supply chain of controlled substances. Drummond Group also serves as an Authorized Testing and Certification Body (ATCB) under the Health and Human Services’ (HHS) electronic health records (EHR) certification program and has certified more than 450 software applications, including e-Prescribing solutions, since its inception in 2010.
For complete press release, please click here.
Last month, Steven Posnack, director of the Federal Policy Division within the Office of the National Coordinator for Health (ONC), wrote a very helpful blog on fact and fiction related to the ONC certification program. We have recently had many questions related to Drummond Group’s involvement in the ONC Permanent Certification program and related certification. Here is our own QA session for questions and how that affects certification from the current Temporary Program.
Question: What is difference between the Permanent Certification Program and the Temporary Certification Program? What about ATCBs and ACBs? Is ANSI now involved in certification?
Answer: The Temporary Certification Program and the Permanent Certification Program are ultimately about the governance of the testing and certification program, specifically, the bodies that are testing and certifying, like Drummond Group. Their work and requirements are, in most ways, outside the concern of EHR vendors and HIT users. Meaningful Use measures and ONC certification criteria are completely separate from the Final Rules governing both certification programs.
The requirements within both programs are very similar. The chief difference is the accreditation method. In the Temporary Program, an organization like Drummond Group was required to take comprehensive tests and submit two sets of quality manuals: 1) for testing plans and processes and 2) for our certification processes. These were approved by ONC itself to be accredited as an ONC Authorized Testing and Certification Body (ATCB). In the Permanent Program, ONC is no longer acting as the accreditation body of either testing or certification although they will still oversee the program. Instead, there is a new ONC-Approved Accreditors (ONC-AA), ANSI, who will do the accreditation for the certification bodies as an ONC-Authorized Certification Body (ACB), and NVLAP, a division of NIST, will run the accreditation program for the testing bodies.
Question: Will Drummond Group be a part of the Permanent Certification Program? Will you also do testing?
Answer: Drummond Group’s intention is to be an ACB (Authorized Certification Body), as well as an NVLAP accredited testing body for EHRs. We are currently working on preparations for approval in the Permanent Program.
Question: When will Drummond Group or others be named as ACBs? Do you have a timeframe?
Answer: We are really hesitant to even speculate on a specific date when ACBs will be open for business given there are many unknowns. Here is what we do know: NIST will be releasing the final testing accreditation requirements for testing agencies around December and will begin processing the applications on Jan. 15, 2012. We have no word from ANSI or ONC on details for applying to become an ACB, nor additional certification body accreditation requirements apart from the core ISO Guide 65.
Also, accreditation is just the first step. Only after you are accredited by ANSI for your certification quality procedures can you submit your application to ONC to be a part of the Permanent Certification program. In the Temporary Program, the submission to ONC to be an ATCB until official approval was a process that took approximately two months.
Question: Will there be new criteria to test and certify in the Permanent Program and will certified EHRs have to return and be recertified with an ACB to remain on the CHPL?
Answer: As stated above, the Temporary and Permanent Program Final Rules are ultimately about the governance of the testing and certification program but not about the criteria which the ATCBs or ACBs will certify. The testing requirements and certification criteria come from ONC separate from anything to do with the current state of the certification program.
Even in the Temporary Program, ONC could revise and update the certification criteria requiring products to be retested and recertified. In fact, they actually did make a revision to the public health surveillance criteria (170.302.l) in an interim rule in October 2010 although it did not require recertification. Eventually, the criteria will be updated when new meaningful use stages are introduced, but that is not connected with the timing or availability of the Permanent Program. Also, certified EHRs will not need to be recertified by an ACB simply because the ATCBs are dissolved with the closing of the Temporary Program.
Question: Once we are in the Permanent Program and new criteria are introduced, such as with Meaningful Use Stage 2, will certified EHRs to have to retest everything previously tested and certified in the temporary program?
Answer: On retesting previously certified criteria, the Permanent Program Final Rule does make a reference to allowing for “gap” certification of new or revised criteria added in later stages versus fully recertifying and retesting all criteria, including those unchanged from previous ONC rulings. However, it ultimately leaves this to the decision of the ACB. We (Drummond Group or any other ATCB) cannot speak definitely on this until we are an ACB and receive further guidance from ONC and possibly ANSI, which is the selected ONC-AA who will accredit us.
Question: In his blog, Steven Posnack stated that current CHPL certification will not expire. However, the certification seals issued in the Temporary Program make reference to 2011/2012. What does that mean?
Answer: Those 2011/2012 Certification Seal dates come from the ONC Final Rule on the Temporary Program, but they are not explicit expirations. Rather, they reflect what was anticipated as the timeline of the criteria and associated Stage 1 Meaningful Use measures.
It ultimately depends upon the current module criteria requirements. If they are not updated, then the certification is still valid.
As a testing company with more than a decade’s worth of experience, we’ve certified many software products across multiple industries. In the process, we’ve worked with quite a few certification and standards-setting bodies.
For the past several months, we’ve been busy in the healthcare industry, working under the auspices of the government’s electronic health records incentive program. As a matter of fact, since becoming an Authorized Testing and Certification Body (ATCB), we’ve certified more than 300 electronic health records systems using a testing script developed by National Institute of Standards and Technology (NIST) for the Office of the National Coordinator for Healthcare Information Technology (ONC-HIT).
Although we’ve tested systems for a variety of standards-setting groups, we weren’t quite sure what to expect when we started working as a testing company under the purview of the Health Information Technology for Economic and Clinical Health (HITECH) legislation – a behemoth government program to say the least.
Much to our delight: We’re really happy with the way things are going so far.
Why? First, we think the leaders in the government program got it right. The powers-that-be managed to develop clear technical requirements without imposing restrictive implementation methods, making it possible to ensure that certified EHRs all perform at a certain level, but also leaving enough flexibility for EHRs to meet specific user needs and for developers to continue to innovate. It’s a tricky balance but one that the ONC seems to have mastered quite well.
As a result, there’s plenty of room for developers to come up with products that push the envelope with new features and functions or to tailor systems to meet the very specific needs of certain specialists such as OB-GYNs, chiropractors or plastic surgeons. At the same time, end-users can rest easy, knowing that software systems that have been certified actually live up to the specifications that will make it possible for them to meet the government’s meaningful use requirements and, subsequently, qualify for their share of the federal government’s incentive funds.
We’re also happy with our work in the program. We feel that Drummond Group has been able to add value to the overall process by infusing a healthy dose of neutrality into the testing and certification process. Steadfastly maintaining neutrality has, after all, been a concept that we have built our company on since the beginning.
Although happy to be a member of the healthcare IT community, we purposely shy away from becoming deeply involved in professional coalitions or advocacy efforts. As such, when we test a product, we test a product. We don’t have to worry about the fact that an industry coalition spoke out against one of the ONC test requirements because our neutrality would keep us apart.
In essence, we make sure we don’t attach to anything else, so that the only thing we are attached to is testing. It’s a singular focus that serves software developers and the overall mission of the HITECH program well.
It’s complicated. That’s how many hospital leaders describe their electronic health records initiatives. These hospitals – instead of having a neat all-in-one EHR solution driving their efforts – have moved toward electronic records by cobbling together a variety of off-the-shelf, customized and possibly even home-grown solutions.
If you work at one of these facilities, you are probably all too familiar with the complications. And, when it comes time to get the stamp of approval needed to qualify for incentive funds, you probably don’t know exactly where to start. No worries. Drummond Group is ready to help. We’re taking applications from hospitals that want to achieve ONC-ATCB 2011/2012 certification for their unique EHR solutions. We stand ready to help hospitals in this situation move forward by testing their solutions to gain the certification required to move toward meaningful use.
Best of all, though, we are gearing up to truly offer more than a cursory certification. With more than 10 years of software testing experience, we have the interoperability know-how that you can tap into to truly get your miscellaneous solutions working together as one unified EHR. Having worked in a variety of complicated industries, we have encountered many difficult software and integration testing scenarios – and have had to evaluate a wide variety of software configurations from the simplest, out-of-the-box applications to complicated solutions derived from a variety of cobbled-together software applications.
What’s more, we are truly committed to meeting the specific needs of healthcare providers. We are presently answering inquiries with hospitals and working on setting up certifications for them. And, while we are ready to start working with you today to qualify your customized or home-grown system for certification, we plan on rolling all of our know-how up into a formal service offering early next year.
Remember, though, to achieve ONC-ATCB 2011/2012 certification, EHR software has to be tested based on the official criteria as defined by ONC. Authorized Testing and Certification Bodies (ATCBs) test and certify the software and then HHS approves and lists these certifications on the Certified Health IT Products Listing (CHPL). Customized programs for hospitals or specific specialties – while designed to help meet the unique needs of various classes of HIT vendors — are not required for the certification that will enable your organization to meet meaningful use incentives.
We’re often asked why we jumped into the healthcare industry. Our answer: It’s simple Business 101 logic. We saw a need and we knew we could fill it.
First, we started hearing from healthcare information technology vendors about the need for software testing. We investigated and discovered that the Department of Health and Human Services (HHC) Office of the National Coordinator (ONC) for Health Information Technology was recruiting organizations to serve as Authorized Testing and Certification Bodies (ATCBs) to provide the stamp of approval to electronic health records (EHRs) that would be used by healthcare provider organizations as they seek to qualify for incentive funds under the American Recovery and Reinvestment Act.
All of this opportunity, of course, piqued our interest. Realizing that we really had something special to offer the healthcare industry, however, made us take the plunge.
Most importantly, we felt that we could offer the efficient and effective software testing that the industry needs –as vendors are scrambling to meet the needs of providers with officially certified EHR solutions. Because we have tested complex software products in a plethora of industries for more than a decade, we have what it takes to get the job done. As a result, vendors can quickly and affordably get their EHR solutions listed on the Certified Health IT Products Listing (CHPL) – and providers can use the solutions to qualify for incentive monies.
Our vision extends beyond the short-term, though. We also realized that we could offer healthcare information technology companies the testing services that they will need as meaningful use requirements evolve—and become more complex. Because of our extensive testing experience, we have become experts in interoperability and privacy issues. Also, we feel that we will be able to help healthcare IT vendors with these issues as meaningful use evolves.
Drummond Group’s ONC-ATCB Certified EHR products have now been posted on the HHS Certified Health IT Products Listing.
Problems viewing the HHS Certified Health IT Products Listing?
Home page of healthit.hhs.gov and look under “What’s New”
Questions? Shoot us an email at EHR@drummondgroup.com
By Sheldon Needle
The real problem of an established medical practice moving into the realm of EHR is not the cost of the medical software package; it is not the training necessary for staff; and it is not security and backups.
The real problem of moving into EMR/EHR is the problem of unstructured medical data.
If you are involved in a new or relatively new practice, this is a no-brainer. Begin with a serious search to compare medical software vendors who are available to answer your questions honestly. It is not truly so difficult to get on a friendly medical screen to enter your patient’s blood pressure or lab test values. You can get used to that.
Neither is it difficult to take notes on a notebook that upload to the EHR system.
The real problem is taking your notes and dictation on a patient that go back 15 years and finding a way to get his possible symptoms, his worry about IBS, his headache history, and his worries over his children into a metrically available rendition that that does not take you or a member of your practices days to decipher. These notes are usually on dictation, hand written notes, and referral letters.
The concerns are many: this can take what feels to be forever, and the anxiety issues and unclear symptoms may not translate easily into metrics but may be critically important in future diagnoses.
There are two critical questions here:
In the long run, it doesn’t even matter if it is worth it. It will happen. Medicine as well as the rest of our cultural world, is becoming electronically-based whether we like it or not. But in the long run, it is worth it. Think of a patient going in to the hospital after a car accident, all by himself, and having all his data available to the admitting doctor in an instant: blood type, history, etc.
Think of a patient being referred to you, the specialist, and having all his patient history available in less than a minute. What a time saver! What insight!
Medical informatics has a number of methodologies it is using to translate unstructured data into useful and structured data.
Three basic methodologies exist to accomplish this:
These methods will be refined, utilized, and integrated in some way into most decent medical vendor software packages over the next few years. For you the physician or practice manager, this may start to pay off in a while, but you still have to get from hand written records into the database.
The obvious way to proceed makes use of our culture idea of, “going forward”:
The real message to practitioners moving to electronic health records is, don’t look at the top of the mountain when you start climbing, just put one foot in front of the other. Delaying the climb will not get you anywhere, but starting the march will move faster than you think!
Having recently spent time as an observer in a hospital setting, I was struck by the lack of intelligent planning and forethought made for doctors trying to move into an EMR / EHR environment.
Though I saw a well-known EHR panel on the computer screens within an ICU, and the EHR being used to record certain patient data, doctors were taking their notes in long-hand. Later on the same day I saw the same doctors transcribing their notes onto their computers. The doctors, doing double duty on note taking were not available to their patients because they were acting as secretaries.
When a large clinical environment is incorporating an EHR it has to be done in a modular way that does not impact productivity any more than it has to. The task is hard enough. If you are using an EHR to record point of care patient information, give your doctors a Notebook so they can take their notes electronically. In fact, insist on electronic note-taking. Incorporate change with some forethought to peoples’ time and effort.
This real-life observation just underscores the need to plan for transition to an EMR rather than throwing an institution into the chaos of change for its own sake, or for the sake of Meaningful Use incentive payments. As in all things, the old US Coast Guard motto holds true: Semper Paratus! Always be ready and prepared.
Most good EMR / EHR systems can offer medical clients some guidance as to best practices in incorporating EMR / EHR systems within their practices.
By Sheldon Needle
The prospects for EHR in the coming year are exciting but more than a little daunting. The issue is really how to find an EMR/EHR system that will organize and centralize the functions of your practice, without bankrupting you and throwing your staff and yourself into turmoil.
If you look at the websites for EMR vendors today, you can see that the functions they describe within their system –the integration of clinical records with practice management data, e-prescription, patient portals — could conceptually do wonderful things for you and for your patients in the way you handle their individual cases, but many of the details are still not working smoothly.
Here are some of the things to be aware of:
Remember, always read the fine print and ask every question you need to. Know that EMR software decisions is a very competitive business. The vendors need you just as much as you need them!
By Sheldon Needle
5010 is not only a date 3,000 years in the future: ANSI 5010 is the newest version of the HIPAA transaction standards regulating electronic transmission of medical and healthcare transactions. The existing standard is called 4010, and 4010 does not support ICD-10 coding.
The current coding standard for diagnosis and procedure coding is the ICD-9, and it has outlived its possibilities –it limits the number of new procedure and diagnostic codes that can be created.
This is how the CMS.gov (center for Medicare and Medicaid services, at: http://www.cms.gov) defines the ICD-10:
ICD-10-CM/PCS (International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System) consists of two parts:
ICD-10-CM is for use in all U.S. health care settings. Diagnosis coding under ICD-10-CM uses 3 to 7 digits instead of the 3 to 5 digits used with ICD-9-CM, but the format of the code sets is similar.
ICD-10-PCS is for use in U.S. inpatient hospital settings only. ICD-10-PCS uses 7 alphanumeric digits instead of the 3 or 4 numeric digits used under ICD-9-CM procedure coding. Coding under ICD-10-PCS is much more specific and substantially different from ICD-9-CM procedure coding.
The transition to 5010 is supposed to happen by January 1, 2012. This means that electronic transmissions including claims, eligibility inquiries and remittance advices must be made in a 5010-compliant format. Healthcare providers, health plans and clearinghouses for transactions are all expected to upgrade their transmissions. Non-compliance may result in claims denied or slower payment.
Systems that are certified as ONC-ATCB for 2011/2012 are already 5010 compliant. If you are contemplating buying a system that is so certified, you do not have to worry about the software compliance, but you do need to educate your staff, including yourself, if you are the physician or the P.A., on what the differences between 4010 and 5010 mean to their everyday work.
If you are using old medical software that has not been updated, or are contemplating installing software that is not certified as ONC-ATCB for 2011/2012, you need to update to a newer version, or face delays and uncertainties in your billing and claims submission. In other words, do some serious upgrading, or else!
By Sheldon Needle
November 30, 2011: Today HHS Secretary Kathleen Sebelius announced incentives to speed the adoption and use of health IT in the form of meaningful-use qualified EHR in doctors’ offices and hospitals nationwide, which will improve health care and create jobs nationwide.
The new administrative actions announced today, which will be made possible by provisions of the HITECH Act, will loosen requirements for doctors and other health care professionals to receive incentive payments for adopting and meaningfully using health IT.
“When doctors and hospitals use health IT, patients get better care and we save money,” said Secretary Sebelius. “We’re making great progress, but we can’t wait to do more. Too many doctors and hospitals are still using the same record-keeping technology as Hippocrates. Today, we are making it easier for health care providers to use new technology to improve the health care system for all of us and create more jobs.”
The press release continues to state: “HHS also announced its intent to make it easier to adopt health IT. Under the current requirements, eligible doctors and hospitals that begin participating in the Medicare EHR (electronic health record) Incentive Programs this year would have to meet new standards for the program in 2013. If they did not participate in the program until 2012, they could wait to meet these new standards until 2014 and still be eligible for the same incentive payment. To encourage faster adoption, the Secretary announced that HHS intends to allow doctors and hospitals to adopt health IT this year, without meeting the new standards until 2014. Doctors who act quickly can also qualify for incentive payments in 2011 as well as 2012.”“ (The italics are ours.)
We need to understand what acting quickly means: buying in 2011? Incorporating EHR within the next month, so that meaningful use occurs in 2011? This is not yet clear.
HHS is redoubling its effort to reach out with information, education, and the possibility of incentive payments to doctors and hospitals and vendors about stepping up the pace of transitioning practices and HER software to meet standards of Meaningful Use. What Meaningful use means to the individual practice depends on size, degree of implementation of the EHR, and the nature of the client base (how many Medicare or Medicaid patients, for instance, figures into the formula of Meaningful Use.
The Obama Administration is working to create a nationwide network of 62 Regional Extension Centers, comprised of local nonprofits, to help eligible health care providers learn how to participate in the Medicare and Medicaid EHR Incentive Programs and meaningfully use health IT.
See the HHS press release, at: http://www.hhs.gov/news/press/2011pres/11/20111130a.html to learn more.
Keep your eyes on the newspapers, government announcements and on this blog to learn about EMR and EHR news and updates.
By Sheldon Needle
You know that your medical practice will have to bite the EMR bullet sooner or later (actually, sooner). The digital handwriting is on the tablet, isn’t it? So what is it stopping you from moving ahead at a planned pace rather than being forced into converting your medical practice to an EMR at the 11th hour?
Here are some of the most common obstacles people face in converting their practices to the use of electronic medical record software, and here are some strategies to deal with them or get the process going:
1. How will we migrate from paper to digital images? Conversion of paper medical records to digital format: If you have your eye on an EMR, learn how tolerant it is of varying formats: does it accept PDF files? JPG format? Ascii text files? Extracts from excel files?
Don’t bit off more than you can chew to begin. If you are practice with reams of folders full of paper files to convert, decide how many years back you need to go in getting your EMR up and running. Perhaps you can start with one year of files via EMR? Or perhaps you need to go much further back?
Look into the possibility of having a consultant specializing in data conversion take charge of your files. There are companies that specialize in just such medical data conversions. If you are really desperate, hire your responsible college students, make the specs clear, and pay her decently!!
2. How will we train everyone in such a new system? Training your self and your staff: Once you have chosen your EMR system, engage the company’s own training staff; that way, you are sure you are being oriented in the current system, using the right documentation. Before you chose your EMR, see what kind of training options the company offers. You might go for a short orientation up front, with a good help desk that is available 24/7. Check reliable Electronic medical records ratings to see which companies provide good in person and on the phone / online support
3. Do we have to set up all the hardware and maintain the software? I don’t think we can manage that. Consider a cloud-based EMR solution: If you are reluctant to invest in a server and commit to the upkeep of hardware and software, consider a Web-based EMR solution, in which you log onto an EMR that worries about security, and updates to hardware and software.
4. How can I compare products so that my practice knows what it is getting into? How much can I trust referrals from other practices? Don’t put all of your EMR decision eggs into one basket: While personal referral are extremely helpful and reassuring, not all are meaningful for your unique EMR practice situation. There are many good EMR products to choose from, and each has its strengths, and its weaknesses.
The right choice will depend as much on the nature of your medical practice and the answers to many questions: What is your medical specialty? How many employees do you have? How expensive is the EMR, per year? How much money can you dedicate to investing in your EMR annually? Can you integrate your medical billing software with your proposed new EMR? Can you afford to hire a dedicated IT employee? How comfortable you and the others in your practice are with using an electronic device as the main source of medical input to your system. These are just a few of the many questions you need to ask yourself.
Talk to people in other practices, yes; but learn to ask the right questions and compare apples to apples and oranges to oranges. Great EMR comparison tools are available to you at no charge, and they can educate you to ask the right questions and maintain a solid baseline for comparison when choosing an EMR.
Ahem….what do we say about privacy and data selling…bingo it appears as if you read through the entire article why else would this type of data be shared with Wall Street Investors to make a market for selling some new analytic algorithms. Now get this the investors got to see this “private” information that a patient can’t even get access to see. This reminds me of ePatientDave, “give me my damn data” and this is a total abuse here as the data is not being used for better care but for “better money”.
Now this also says something about access to revenue cycling too, payers and integrators might want to visit this scenario and make sure that it stays on a server for one and what levels of access will be granted. Now this gets worse as the types of information and patients were related to mental health, HIV, Parkinson's and more. How many investors glazed over these records? Accretive gets paid on the revenue boost is provides. There are a lot of these types of 3rd parties around in healthcare and here’s another one used by Blue Cross who had some bad algorithms.
Actually when it comes down to payer disputes you wonder did the hospital bill erroneously on purpose or did they get some bad algorithms and a bunch of promises? If I were one of these patients, court might be on my mind and I would want to know what investors on Wall Street potentially or did see my data! On their website they talk about bringing increased discipline to the revenue cycle so is that the revenue cycle on Wall Street?
Well Fargo just dumped one of these types of companies recently and remember the big data breach at Stanford, also the fault of a 3rd party, so with history being built here who wants to trust a 3rd party today if you don’t have to as patient records end up on the web and in the hands of investors on the street. The 3rd party folks are the algorithm makers though that promise better profits and use of money. This whole scenario though is kind of sad as they were supposed to be helping a couple non profits boost their revenue but the hospitals probably had no clue on the methodologies like showing patients records was in the plan.
“The screen shot also includes numeric scores to predict the “complexity” of the patient and the probability of an inpatient hospitalization, and a box to describe the “frailty” of the patient.”
Tine to start licensing and taxing those data sellers and have a federal disclosure site so we all know what’s going on, beginning to make more sense every day! The link below will describe a bit of this brainstorm. BD
ST. PAUL, Minn. - Minnesota Attorney General Lori Swanson has filed a lawsuit against a debt collector accused of failing to protect the confidential information of 23,500 hospital patients after a company laptop was stolen from a rental car parked in the Seven Corners are of Minneapolis.
The lawsuit filed Thursday alleges Accretive Health, Inc., a debt collection agency that is part of a New York private equity fund conglomerate, failed to protect the confidentiality of patient health care records and failing to disclose its involvement in their health care.
Last July, Accretive lost a laptop computer containing unencrypted health data of about 23,500 patients of two Minnesota hospital systems -- Fairview Health Services and North Memorial Health Care.
Under both contracts, Accretive controls and directs the work of hospital employees and “infuses” its own employees into the staffs of the hospitals. Accretive gets base compensation and incentive pay for helping the hospitals boost revenue or cut costs.
“The debt collector found a way to essentially monetize portions of the revenue and health care delivery systems of some nonprofit hospitals for Wall Street investors, without the knowledge or consent of patients who have the right to know how their information is being used and to have it kept confidential,” Swanson said.
The state seeks an order requiring Accretive to fully disclose to patients:
- What information it has about Minnesota patients
- What information it has lost about Minnesota patients
- Where and to whom it has sent information about Minnesota patients
- The purposes for which it amasses and uses information about Minnesota patients.
One more the mergers and acquisitions speak out again on how health insurance companies have diversified their portfolios and are no longer “just an insurance company” with numerous subsidiaries both in the Health IT area and even others in what you might consider “unrelated” businesses. Here’s one example below with a diversified interest with a new division created to distribute hearing aids and offer incentives for those in certain areas of the us to sign up for insurance plans. I sometimes wonder how other insurers view this?
Here’s another example of what one might consider a business outside of what we might normally consider a related business with low incoming housing investments in New Mexico. One thing to keep in mind today is all the aggregated data that flows and the algorithms and SQL statements that bring some of this together. Data is big business.
Just a couple weeks ago we read about the investment with mobile health and again we venture down into the data business here again as the Optum division which has many subsidiaries has a huge focus on data, and part of the renamed group was the old “Ingenix” company that has consulted and provided data services for years and last year settled their case with the AMA with short paying providers for out of network services.
This kind of brings me around again to what I call the “Alternative Millionaire’s Tax” with companies that buy and sell data and this seems to be a good place for a mention here as the Optum Division has been making money for years with aggregating and selling prescription and other data. With big profits as such we certainly could entertain a license and tax situation for those making billions on the data selling business. As a short comparison from another Healthcare company, Walgreens has estimated their data selling business to be valued at just under $800 million, so again something to give some thought to as hospitals, providers, and patients struggle to afford medical care today.
Another good article to read about the over sell and naïve and gullible nature of the US with both government and consumers, read what Nanex has to say as they are the folks that monitor and study rogue algorithms in the stock market and look for indicators of the “next flash crash”. A couple paragraphs are below and will the SEC be suckered in to this huge expense of programmers who want to make big dollars writing code convince a naïve and gullible SEC? It’s all over the place with digital illiteracy, steroid marketing and algorithms for huge profits only and they have teeth. At a certain point in time we might need to REALLY think about the value of some of the data we analyze today and the cost and this is worth a mention as this is the big growth area for United, algorithms and software analytics via consulting services. It is also worth a note that United last year hired the former Assistant Attorney General for the State of Minnesota for their general counsel.
Below is one example of the algorithm/software business as the company created a clearinghouse business and collaborated with an medical records company to integrate the services with Epic and of course this means more data revenue for the company and puts a bit of stress on other smaller existing clearinghouse businesses in the US as well.
One more thing too is let’s not forget that they also own a bank with over $1 billion on deposit with health savings accounts and I would guess this also leaves them open to lend money on monies held here and somewhat compete with other banks. As you can read in the quote below the funds are largely generated by employers, in other words large US corporations so they seem to go hand in hand, right?
“OptumHealth offers three types of HSAs, as well as tax-advantaged health care savings and spending accounts, debit-card services, benefits administration services, and payment products. About three-quarters of the bank’s 1.6 million accounts are employer-generated, while the other quarter are individual accounts.”
There’s also the Chinese investment the company bought early in 2010.
If you were to stop and look you might also notice one more subsidiary that can consult with biotech and device companies to introduce new products to the FDA and you know when you think about it they might just have a subsidiary to handle the entire process from FDA approval all the way down to provider reimbursement too.
One other related item too is the purchase of physicians groups which is growing and the acquisition of Monarch in Orange County is one big example of buying a huge managed care group.
Again, in summary with such large profits and a lot coming from the data end of the business, this looks like one company where licensing and taxing the data sold for huge profits could fit and there are many more as Hedge Funds, Facebook and tons of other companies are cashing in royally and this all leads to bottom line profits for running algorithms on servers 24/7 that you can’t see, touch or talk to as far as the consumer is concerned, but automated algorithms for data mining and selling are yielding huge profits for corporate USA while as consumers we are becoming “data chasers” to fix a lot of the flawed data that is out there today. It’s a good idea today to read up and see how the corporate USA scene has changed tremendously due to the huge array of mergers and acquisitions as companies are not the same ones they were 2 to 3 years ago by any means. BD
UnitedHealth Group (NYSE:UNH) today reported fourth quarter and full year 2011 results, highlighted by strong enrollment and revenue growth in each of UnitedHealthcare’s benefits businesses and strong revenue growth at all Optum business units. Full year and fourth quarter 2011 net earnings were $4.73 per share and $1.17 per share, respectively. Cash flows from operations were $7 billion in 2011.
The Company continues to estimate 2012 revenues in the range of $107 billion to $108 billion and net earnings in the range of $4.55 to $4.75 per share.
Is there money in those algos? This story might answer that. Why would this employee who was a contracted programmer take this code? It’s worth money and if you read often enough you know I discuss those algos and software is nothing more than a group of algorithms, words of Bill Gates.
A co-worker said the employee said the accused confused he lost the drive containing the code and get this, it’s the software (aka algorithms) that cost $10 million to develop to track the billions of dollars that the US government dispenses “daily” to government agencies..these are some pretty commanding algorithms…so the programmer apparently took the code and who knows where it would go next? A lot of government code is open source but don’t think that is the case here…what’s the next security breach to occur? BD
Bo Zhang, 32, of Queens, New York, worked as a contract programmer at the bank. He was accused of illegally copying software to an external hard drive, according to a criminal complaint filed in U.S. district court in Manhattan.
Authorities said the software, owned by the U.S. Treasury Department, cost about $9.5 million to develop.
A New York Fed spokesman said in a statement that the bank immediately investigated the suspected breach when it was uncovered and promptly referred the matter to authorities.
Zhang told investigators he took the code "for private use and in order to ensure that it was available to him in the event that he lost his job," the complaint said.
The code, called the Government-wide Accounting and Reporting Program (GWA), was developed to help track the billions of dollars the United States government transfers daily. The GWA provides federal agencies with a statement of their account balance, the complaint said.
This is kind of an alarming incident but when you read further it does not stop the treatment process and the secondary outbursts are surgically removed. This affects about half of those treated to be on alert, but not all of those develop the secondary skin cancer, only about a quarter of the 50% risk group.
This sounds like a big step in recognizing undesired side effect with oncology treatments. BD
Drug Used to Treat Melanoma with One Mutation Sets off a Cascade that Results in a Different Type of Skin Cancer in Cells with Another Mutation
Patients with metastatic melanoma taking the recently approved drug vemurafenib (Zelboraf®) responded well to the twice daily pill, but some of them developed a different, secondary skin cancer.
Now, researchers at UCLA’s Jonsson Comprehensive Cancer Center, working with investigators from the Institute of Cancer Research in London, Roche and Plexxikon, have elucidated the mechanism by which vemurafenib excels at fighting melanoma but also allows for the development of skin squamous cell carcinomas.
The very action by which the pill works, blocking the mutated BRAF protein in melanoma cells, sets off a cellular cascade in other skin cells if they have another pre-disposing cancer mutation and ultimately accelerates the secondary skin cancers, said Dr. Antoni Ribas, co-senior author of the paper and a professor of hematology/oncology.
About 50 percent of patients who get melanoma have the BRAF mutation and can be treated with vemurafenib, Ribas said. Of those, a fourth of the patients develop skin squamous cell carcinomas. The squamous cell carcinomas were removed surgically, and vemurafenib was not discontinued for this side effect.
“We wondered why it was that we were treating and getting the melanoma to shrink, but another skin cancer was developing,” said Ribas, who studies melanoma at the Jonsson Cancer Center. “We looked at what was likely making them grow and we discovered that the drug was making pre-existing cells with a RAS mutation grow into skin squamous cell cancers.”
The 18-month study appears in the Jan. 19, 2012 edition of the New England Journal of Medicine.
The combined research team performed a molecular analysis to identify the oncogenic mutations in the squamous cell lesions of patients treated with the BRAF inhibitor. Among 21 tumor samples studied, 13 had RAS mutations. In a different set of 14 samples, eight had RAS mutations, Ribas said.
“Our data indicate that RAS mutations are present in about 60 percent of cases in patients who develop skin squamous cell cancers while treated with vemurafenib,” Ribas said. “This RAS mutation is likely caused by prior skin damage from sun exposure, and what vemurafenib does is accelerate the appearance of these skin squamous cell cancers, as opposed to being the cause of the mutation that starts these cancers.”
Ribas’ group found that blocking the non-mutated BRAF in cells with mutated RAS caused them to send signals around BRAF that induced the growth of the squamous cell cancers.
The discovery of the squamous cell cancer mechanism has led to strategies to inhibit both the BRAF mutation with vemurafenib and block the cellular cascade with a different drug, a MEK inhibitor, before it initiates the secondary skin cancers, said co-senior author Professor Richard Marais from the Institute of Cancer Research in London, who developed the animal model for the study.
“By understanding the mechanism by which these squamous cell cancers develop, we have been able to devise a strategy to prevent the second tumors without blocking the beneficial effects of the BRAF drugs,” Marais said. “This may allow many more patients to benefit from these important drugs.”
Ribas said that this is one of the very few times that oncologists understand molecularly why a side effect to cancer treatment is happening.
“The side effect in this case is caused by how the drug works in a different cellular setting,” he said. “In one case it inhibits cancer growth, and in another it makes the malignant cells grow faster.”
Studies currently are under way testing BRAF and MEK inhibitors in combination in patients with metastatic melanoma, Ribas said.
“Our data provide a molecular mechanism for the clinical toxicity of a targeted oncogene inhibitor that apparently contradicts the intended effects,” the study states.
The study was supported by Roche, Plexxikon, the Seaver Institute, the Louise Belley and Richard Schnarr Fund, the Fred L. Hartley Family Foundation, the Wesley Coyle Memorial Fund, the Ruby Family Foundation, the Albert Stroberg and Betsy Patterson Fund, the Jonsson Cancer Center Foundation and the Caltech-UCLA Joint Center for Translational Medicine.
UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers and clinicians engaged in disease research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating basic science into leading-edge clinical studies. In July 2011, the Jonsson Cancer Center was named among the top 10 cancer centers nationwide by U.S. News & World Report, a ranking it has held for 11 of the last 12 years. For more information on the Jonsson Cancer Center, visit our website at http://www.cancer.ucla.edu.
Jon goes back to Foxconn-revisited…in his usual style and he says we need to make our factories look more like those in China. Workers live in dormitories and don’t know each other, cuts down on commuting and friendship.
Workers are finding ways of improving their conditions, hotlines with trying to stop suicide and put nets around buildings to catch jumpers…I think we remember this from a year ago and he says in the US we call this “treating the symptoms”.
“It’s me, Siri, in your pants pocket working on giving you testicular cancer”…If it works for those factories, electronics would cost more..modern work fare…a game to the rescue…this is great humor but there are somethings I does make one ponder…there’s just one level and this is it…(the middle class) as algorithms are marketed and designed and sold to consumers.
He shows the work of the algorithms in place for sure in a humorous way. Why are health insurance companies getting into the low income housing business though? I hope this is not a Foxconn plan to create communities with jobs that pay little and have medical care on campus? What is up with this?
The same company owns a subsidiary that will basically give you a free hearing aid made in China if you sign up for their health insurance…more below…and the subsidiary they built to distribute and coming to Walmart soon as I understand…
He moves on to the next part, a game that has one level…hmmm…we another insurance company banking on this too…data to sell? Will this make you healthy? I prefer real knowledge.
I just ask is there where we are headed with mining and selling data today and big corporations taking over our day to day decisions? The more information they have to judge and discriminate, the ability to control and humiliate the middle class grows.
At any rate with the use of algorithms today that have teeth and the amount of flawed data out there, are we going in this direction? I put this out for an awareness and perhaps to generate some though processes. I like technology and the good things it brings but am not oblivious to how it can also be abused as well and a NYU professor says it even better than me, read and listen up.
I sure hope Richard Cordray understands math and the power of the algorithms when used both in an intuitive and good manner and the reality of those who design for pure profit that hurts consumers. You can see, smell or touch them, but they are running on server 24/7 every day making like impacting decisions, crafted by some of the smartest programmers and developers that the money on Wall Street can buy.
Another good article to read about the over sell and naïve and gullible nature of the US with both government and consumers, read what Nanex has to say as they are the folks that monitor and study rogue algorithms in the stock market and look for indicators of the “next flash crash”. A couple paragraphs are below and will the SEC be suckered in to this huge expense of programmers who want to make big dollars writing code convince a naïve and gullible SEC? It’s all over the place with digital illiteracy, steroid marketing and algorithms for huge profits only and they have teeth. BD
“Wall street hires the best software developers money can buy. They write clever algorithms. These algorithms will only get more clever as time goes on. Which means they will always be changing. Now, writing software to detect what other software is doing is 100 times more difficult. Which in the software world means 100 times more expensive. Which means hiring people that do not exist, since Wall Street already snapped up the best, and you need the best times 100 (you can't make it up in quantity and just get 100 times more wizards, because many will have poor social skills, and you need these people to communicate).”
“You see the folly of trying to regulate the markets in real-time? Real-time raises the cost exponentially times a million. To a level that all the kings in the world couldn't afford. It would be one thing to track in real-time, things that had known behavior. Like your checking account being overdrawn. Maybe credit card fraud in the making (which, by-the-way, hasn't been perfected yet, despite lots of money and time thrown at the problem). “
To go back a little bit in time the chip was also set up to communicate with personal health records like Healthvault. The latest development on the chip was the ability to communicate real time glucose readings. The FDA has approved the product and the HealthLink software.
In addition, Medcomp who makes vascular access catheters will use the chip in vascular ports for identifying the port in a patient for proper medication dispensing. As it read here though the use with Medcomp still needs to secure FDA approval. This chip keeps coming back around with many lives. BD
DELRAY BEACH, Fla., Jan 17, 2012 (BUSINESS WIRE) -- VeriTeQ Acquisition Corporation ("VeriTeQ" or "Company"), a marketer of implantable, radio frequency identification ("RFID") technologies for patient identification and sensor applications, announced today it has acquired the VeriChip implantable microchip and related technologies, and Health Link personal health record from PositiveID Corporation. VeriTeQ is majority owned and led by Scott R. Silverman, former Chairman and CEO of PositiveID and VeriChip Corporation. PositiveID has retained an ownership interest in VeriTeQ.
VeriTeQ will focus on three main areas: patient identification and personal health record (PHR) access through the VeriChip implantable microchip and Health Link web-based PHR; implantable sensor applications; and identification of medical devices within the body. VeriTeQ will also focus on identification and sensor applications for animals.
VeriTeQ's acquisition also includes the rights to a Development and Supply Agreement with Medical Components, Inc. ("Medcomp"), a leading manufacturer of vascular access catheters. Under the terms of the agreement, Medcomp will embed the VeriChip microchip in its vascular ports to facilitate identification of the port in a patient and proper medication dispensing.
Doctors’ adoption of health information technology doubled in two years, according to a new report, Department of Health and Human Services Secretary Kathleen Sebelius released Wednesday. Sebelius also announced extension of the meaningful use qualification date to 2014. See link for more info – http://www.healthcareitnews.com/news/hhs-extends-mu-stage-2-deadline-spur-faster-emr-adoption?topic=01,08
The survey I posted earlier has now been completed – here are the results.
High physician fees, rather than factors such as practice costs, volume of services or tuition expenses, were the main drivers of higher U.S. healthcare spending and physician income, according to research presented in the September issue of Health Affairs.
The study, conducted by Miriam J. Laugesen, PhD, and Sherry A. Glied, PhD, both of the Mailman School of Public Health at Columbia University in New York City, found that in some cases, physicians in the U.S. are paid as much as double their counterparts in other countries. There is also a larger gap between fees paid for primary care and fees paid for specialty care, particularly orthopedic surgeons, in the U.S. compared to other countries evaluated by the study.
Fees paid by public and private payors for primary care office visits and hip replacements were compared in six countries: Australia, Canada, France, Germany, the U.K. and the U.S.
Laugesen and Glied found that primary care physicians in the U.S. were paid, on average, 27 percent more by public payors for an office visit, and 70 percent more by private payors for an office visit, compared to the other countries. The largest difference in fees paid between countries was for hip replacements. Physicians in the U.S. were paid 70 percent more by public payors and 120 percent more by private payors for these procedures as compared with physicians in the other countries.
Across the fees analyzed by the study, the biggest disparities in pay to U.S. physicians existed on the private side. Fees paid by private insurers in six markets in the U.S. averaged about 33 percent above Medicare rates for primary care and 50 percent above Medicare rates for hip replacements.
“Our analysis suggests that policymakers in all countries need to consider how differential prices paid by both public- and private-sector payors to specialists influence specialty choices,” wrote the authors. “Furthermore, this analysis suggests a need for greater standardization of cross-national data on the nature of physician services provided, fees, education and incomes to allow ongoing comparative research on the relationship between prices and healthcare spending growth.”
Incomes were also higher for U.S. primary care and orthopedic physicians compared to their foreign counterparts.
The authors said other factors thought to contribute to physicians’ fees, such as high medical education tuition costs for American physicians or increased work volume, could not fully explain the disparity in fees when compared across the countries.
“Although the tuition cost of medical education in the U.S. borne by individuals is substantial, it cannot fully account for the observed differences between the earnings of U.S. physicians and physicians in all other countries,” wrote Laugesen and Glied.
For the services examined by the study, higher physician incomes did not appear to be due to a higher volume of services, though the authors acknowledged the rates of other procedures not studied may be higher and contribute to the elevated fees and incomes.
One possible explanation offered by the authors for the high U.S. physician fees was the notion that higher fees may reflect the cost of attracting highly skilled candidates. When physician fees in each country were compared to the mean incomes of the top 1 percent of households within that country, the results were broadly consistent, suggesting higher U.S. fees were the result of a “society with a relatively more skewed income distribution,” according to Laugesen and Glied.
The New York Times (9/6, B1, Freudenheim, Subscription Publication) reports, “Under heavy pressure from government regulators and insurance companies, more and more physicians across the country are learning to think like entrepreneurs.” One result is the rapid growth in joint M.D./M.B.A programs to 65 at present with an estimated 500 students. Some intersperse business courses with medical courses while others have students complete their medical training and add a year or more of business education. “Dr. Barry R. Silbaugh, chief executive of the American College of Physician Executives, a professional society that provides medical education courses and career counseling, said more start-ups were being run by doctors.” He explained that some “are focused on adapting technology to health care, not just electronic medical records,” adding, “The use of social media is of great interest to many younger physicians, and so is health care analytics.”
John Halamka presents his ideas about the major issues for 2012..
ICD10 - John predicts 25% of IT capacity will be consumed by ICD10 this year. Not good...
Meaningful Use Stage 2 including inpatient clinical documentation - now this is exciting. Potential criteria will likely include improvements to clinical records that improve care coordination and communication between providers. John suggested use of templates and social-networking like group documentation.
ACO Planning - The reform changes for ACOs will include focus on prevention and wellness. New business intelligence (BI) and clinical decision support (CDS) capabilities will be helpful in meeting these goals.
Compliance - Compliance issues will include "conflict of interest tracking, learning management systems for compliance education, and enhanced revenue cycle systems that provide decision support."
Security - yes, the past year had a long list of data breaches, malware, and mobile devices so security of PHI must be improved, particularly if we intend to move clinical decision support to the bedside or engage in Health Information Exchanges.
NPR topics presents a summary of the impact to the Affordable Care Act in a discussion between Audie Cornish and Noam Levey of the Los Angeles Times.
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Recently the ONC posted on the Health IT Buzz Blog about the "challenges providers face in achieving Meaningful Use of electronic health records (EHRs)."
The concept of "useability" has long been known in other industries where new technology or applications enter the workplace. Some time ago I wrote about usability of health IT, however I expanded the definition to include a few more "E-bilities" as shown in the following graphic contained in the post: Part 4 of The Value of the Internet for Improving Healthcare.
This is the last post in the series and it focuses on capabilities, or "e-bilities" of technology to improve healthcare. Regardless of the mode of use (e.g. email or internet), technology must be easy to use, secure, reliable, and accessible.
For the past year, the SHARPC-Project 1 has focused on making use of technology easier for clinicians. One ONC staff member, Jacob Reider, MD had some interesting comments that focused on "The User Experience." His comments spanned the continuum of User Experience with a framework for how tools and/or applications can/should evolve.
Functional (it does what it is claimed to do)
Reliable (it works consistently)
Usable (it works in a way that is consistent with the user’s expectations)
Meaningful (it does something important or valuable)
Pleasurable (it is enjoyable to use)
So, I will end with one thought. Even if the system meets "Useability" standards for clinicians, achieving quality health data analytics still requires that accurate, timely and quality data is entered into the EHR avoiding the Garbage In-Garbage Out phenomenon.
This article in Healthcare IT News caught my eye. A white paper written by the Care Continuum Alliance described significant market movement toward accountability and value driven healthcare outcomes as a result of collaborative models, such as ACOs. However, there are 8 key issues that could affect population health management in 2012:
Each of these items contains a plethora of complex issues that will require agreement, alignment, and cooperation between distinct parties. In order to simplify my thoughts on this topic, I offer the following.
Accountable care and collaborative models certainly provide the opportunity with electronic records to capture and disseminate research and/or de-identified clinical data for surveillance. The link to "accountability" also provides the impetus to develop predictive analytics, a personal favorite.
It is well known that mobile technology, including smart phones, are changing the nature of "computer use" and internet access. According to the article the author stated that "a patient-centered, consumer-empowered, pull-rather-than-push model will dominate, with social media in a position of importance."
Reducing re-admissions? Well, we should already be doing this, unfortunately the quality of healthcare in certain situations, or the variable factors in a patient's condition and care makes this a tough goal to reach all the time. However, Medicare tracking is looking a 3 conditions - heart failure, acute myocardial infarction and pneumonia.
Finally, the other items tout the value of competitive forces in healthcare resulting from support of "insourced programs," development of health insurance exchanges in 2014, and the single idea that is near and dear to a nurse - support for prevention and wellness!
Prevention and wellness has not been a priority for most clinicians due to its non-reimbursable status. Let's hope that changes. Since the Prevention and Public Health Fund is under discussion, Medicare added annual wellness visits and expanded coverage of obesity and cardiovascular disease prevention services.
2012 brings a year of great change and challenge. Best wishes to all for a safe, happy, and prosperous new year!
As clinicians, do we ever wonder how excellent patient care can be achieved? Do we become too involved in our deadlines, our tasks, or our own needs and lack the time to reflect and to improve? It is certainly an issue in today's healthcare environment as the delivery of care changes in the path to Meaningful Use...
Well, I watched this video today, posted by Brian Ahier. It is an epic portrait of how one individual came up with an idea that would provide quality care/experience to customers.
Click this link to watch the video - a moving and heart-felt story.
May you have a Happy and Safe Holiday Season!
The HIPAA Survival Guide's Privacy Rule Under HITECH Webinar will help get you up to speed on how the HITECH Act has impacted the HIPAA Privacy Rule and how marketplace trends are impacting it as well. The webinar will walk you through the Privacy Rule and discuss the effect that the HITECH Act has had under three major sections: 1) uses and disclosures of PHI contained in sections §164.502 through §164.514; 2) the Patient's Bill of Rights contained in sections §164.520 through §164.528; and 3) the Administrative Requirements contained in Section §164.530.
Date: December 13, 2011.
Time: 2:00 to 3:30 EST.
To register CLICK HERE.
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I received several items in my email regarding different organizations’ proclamations for 2012. Most of them predict that 2012 will be the year for mHealth to ‘break-out.’ Here are 5 examples:
One might ask, what is mHealth? It has many different definitions and from a product offering perspective could range from texting information on a mobile phone to a provider and/or specifying a provider geographical location to a patient to bi-directional interaction with a medical device to/from an electronic medical record application via mobile phone or telecommunications frequencies (or the medical device could be embedded with the mobile telecommunication appliance). As with the traditional Healthcare industry, as one progresses up the interaction functionality chain, the design and interoperability gets more complex. Most of the latest news items I read about successful mHealth applications describe the ‘easier’ applications: texting, scheduling, location, etc. There is still growth and development in the marketplace for interactive medical-device integrated/connected products. Additionally, from a market perspective, most of the current product offerings are proprietary in nature and vertically integrated.
Mobile telecommunication vendors are keenly interested in providing for the healthcare market. They are closely watching as well as working to influence the regulatory environment. From a provider perspective, this means adding another large player to the mix. You may already provide some internal mobile telecommunications support, but providing healthcare monitoring over that infrastructure changes the rules of the game. In addition, the mobile telecommunications market plays to the consumer market, which has faster turnaround times, and higher customer expectations. The consumer market expects the ability to smoothly transition service when changing a ‘product provider.’ In addition, with social media, the pressures are higher; witness the recent policy and product turnaround of Verizon to a charge for customers using a specific billing mechanism. The healthcare provider is not used to this type of oversight or pressure yet.
Down in the healthcare provider trenches, testing remote monitoring and the use of mobile telecommunications offerings continues. Here in Europe there are two larger projects that are interested in demonstrating the efficacy of remote monitoring. One, the Whole System Demonstrator based in England and their National Health System (NHS), has just published its preliminary results. Another, Renewing Health, is based on a nine European country pilot for remote monitoring of chronic diseases. In the case of the Whole System Demonstrator, initial results have been very positive for the clinical outcomes regarding the use of remote monitoring models for chronic disease management with a “15% reduction in A&E visits, a 20% reduction in emergency admissions, a 14% reduction in elective admissions, a 14% reduction in bed days and an 8% reduction in tariff costs” along with a “45% reduction in mortality rates.”
Renewing Health is still in its trial period, however, the initial technical results have been published. A basic summary of the technical aspects of the nine solutions follows:
This project will be ongoing until 2013 and at the end the results are hoped to strengthen the hypothesis that well designed remote monitoring programs for chronic disease management is as or more effective than care delivered in the traditional manner. There should also be some interesting results from a technical perspective. The market is slowly moving towards providing more standards-based products, however, for the purposes of this project, timing did not allow more adoption of those types of products.
So, with all of the activity described above what should healthcare providers do? I suggest the following:
So is 2012 the year of mHealth? Perhaps. If anything, it will be another exciting year for mobile technology and the convergence of the consumer and healthcare industries. It will be bumpy, but in the end, it should be better for the consumer who usually also happens to be the patient.
A recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.)
The use of the product in question was given as:
Curiously only one customer was identified as having received the product, or at least this particular version of the product. While the manufacturer and product in question is a matter of public record, and available at the link, I chose not to include it here because my objective is not to repeat the recall information, but to suggest the reasons for the recall, an associated labeling issue, and offer some general lessons.
The reason given for the recall had two seemingly separate parts. The first is that “The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage”. This sounds like a software problem yet the fix was not to “upgrade” the software but to suggest a workaround. (I love the term upgrade to when applied to fixing something that doesn’t actually work!) According to the FDA the firm’s letter stated that “users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended.” (I did not find the firm’s letter on its website, but it might be one of those hidden page situations since I did find, with a struggle, two other recalls, though using the search term “recall” produced no results). Again speculating, the workaround sounds like a user dependent way to do something that was supposed to happen automatically. At least part of the value of automation is largely diminished, and opportunities for use error increased, when such additional demands are placed on the user.
The second reason given for the recall was that there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the central station. This is an interesting technical issue that may be related to software and/or communication protocols. In either case it illustrates that multiple data streams may only be useful if they are properly timed stamped, and then properly aligned at the receiver. Out-of-sync data when subsequently processed either by eye, or automatically, can give erroneous and misleading results that might appear to be correct, i.e. the results could be in the category of erroneous but believable.
For one or both reasons the FDA found that, “This product may cause serious adverse health consequences, including death.” Yet it should be noted that this was a voluntary recall, as most recalls are, despite the fact that people who surely know better reported this as “FDA recalls…”
The FDA announcement goes on to say that the company pointed out that the instructions for use state that: ”For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the…Central Station only for remote assessment of a patient’s status.” This sentence seems to be illustrative of the fundamental problem of remote information receivers and integrators that carry a disclaimer that in sum says that you shouldn’t rely on them. But isn’t the ability to rely on it exactly why you bought it? Moreover, promotional materials available on the web do not appear to echo this disclaimer. For example it is stated that ”Applications…enhance patient care management by providing rapid assessment, decision support and clinical reporting.” Does that sound like it isn’t for primary diagnosis? Or does “Data accessible from the…Central Station includes real-time waveforms” sound like those waveforms shouldn’t be used for primary monitoring? For one more example it is said that “arrhythmia events are detected with an unprecedented degree of accuracy.” Accuracy is certainly a good thing, but detecting arrhythmias at the central station when only the beside monitor is to be used for “primary monitoring and diagnosis” appears to be less than highly useful.
Furthermore the statement that the central station is only for remote assessment seems both definitional and contradictory. It is obviously for remote assessment–because it is a central station and thus remote! But then what does “assessment of the patient’s status” mean if not monitoring and diagnosis?
The disclaimer game has been addressed in these pages before. Here it seems to involve a product that is being marketed, sold and bought for exactly the reasons that the manufacturer is saying it shouldn’t be used. I didn’t spot the disclaimer language in any of the promotional materials, but maybe it is there somewhere.
So, we have here an apparent example of software driven miscalculations, network transported data that is not time synchornized, and a reminder not to use the central station for primary assessment. Important examples to remember as we charge ahead with software driven networked solutions.
[The products in the photo with this post above are not associated with the recall discussed, and are for illustrative purposes only.]
The issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both EHR and EMR) to include other related electronic information tools collectively called health IT.
The potential for health IT to improve both the quality and efficiency of medical care has been much noted to include more complete and timely records, ready exchange of information between providers, clinical decision support, and in turn a reduction in errors associated with the quality and availability of patient information. Efficiencies may arise from electronic capture of data which would eliminate manual entry, and time savings in accessing and reviewing patient information, and perhaps in passing information to third party payers. Additional public health value might accrue from the enhanced searchability of electronic records with respects to trends, treatments and outcomes. These benefits assume well designed, user friendly, compatible systems not withstanding that the U.S. model is to allow for numerous independent products that may or may not be able to exchange information nor display it in a consistent manner. Not surprisingly the report notes that the IT imperative will likely not be fruitful without associated attention to the people and the clinical system they work in.
However there is also the potential for health IT to add to, rather then reduce complexity; misplace, lose or garble patient information, and to provide clinical decision support that is incorrect or unreliable. Thus health IT itself has risks that the IOM found have not yet been adequately addressed or monitored. The IOM also cites the lack of an effective health IT problem reporting system compounded by contractual language that may actually impede such reporting. In addition some vendors include disclaimers as to their responsibilities even for software defects and errors. The latter suggests the all purpose liability disclaimer language: “Notice-this product may be badly designed and therefore not suitable for its intended purpose.” Alternatively one could try: “Due to software defects the information in this EHR may or may not be complete and/or may not pertain to the patient of interest. Do not use this information for medical treatment”. The value of such disclaimers will no doubt be tested.
Of course it is not only coding defects that can make heath IT less than effective. The well established issue of usability, or user friendliness, lives on, as does interoperability, training and workflow design. In this regard it might be noted that user friendly features such as pull down menus also facilitate quick but erroneous entries. Thus while an IT product might be theoretically capable of being used properly and effectively, whether it will achieve that goal in the real environment of use, when used by real people, is a separate matter. In this regard when faced with use issues and adverse events vendors will want to say that their product could have provided the correct functionality if only it had been used correctly–and don’t forget our disclaimer. The counter argument is that it was badly designed to the degree that “correct” use was predictably not likely to consistently occur. There are many anecdotes in this regard. A favorite of mine was an order entry system to which was added a physical sticky note on the monitor that read “Do not press Enter to Enter”.
Actual health IT hazards are at least in part separate from the questions of privacy, hacking and other mischief.
It must also be remembered that quantitative data (e.g. lab results and other medical device data), or reasonably well standardized data (e.g. images) are potentially much easier to capture, transmit and display than narrative information. The selection and arrangement of information on a display can also be a significant challenge with respect to density, utility and how many pages the clinician has to look at to get all the information needed–and you can’t spread those pages out. There is also a significant issue with the lack of standardization of “look and feel” factors. In this regard it must be remembered that clinicians of various types, working in multiple environments, might see multiple systems during even a single day. This is analogous to the reality of nurse use of infusion pumps. Ask the nurse if they know how to use an infusion pump and they will most likely say yes (and be insulted). But then ask them if they know how to use a particular infusion pump and they might say, no, I’ve never seen one of those before. In this regard a health IT application may be plug-and play, but that isn’t the same as plug-and-effectively-use.
The report has several specific recommendations:
Readers familiar with the FDA regulation of medical devices will recognize many of these items as standard fare. These include registration and listing, quality systems, and problem reporting. However since the FDA has not asserted that EHRs are medical devices, and the IOM elected not to make that specific recommendation.
Record-type health IT products remain in a regulatory vacuum–except with respect to acquisition funding subject to the meaningful use requirements. In this regard the report includes a dissenting statement from Richard Cook, MD (director of the Cognitive Technologies Laboratory at the University of Chicago) who asserts that health IT products should not only be declared to be medical devices, but that they should be Class III, the most stringently regulated device classification. In this regard he includes the following quote: “Medical and diagnostic devices have produced a therapeutic revolution, but in doing so they have also become more complex and less easily understood by those who use them. When well designed, well made, and properly used they support and lengthen life. If poorly designed, poorly made, and improperly used they can threaten and impair it.” While this quote could appear in nearly any one of the posts here, it actually dates to 1976 as part of President Gerald Ford’s signing statement for the Medical Device Amendments that ushered in the modern era of medical device regulation. While these amendments are often thought of as the beginning of FDA medical device regulation, such regulation actually stems from the 1930′s. What did start in 1976 was before-marketing restraints as opposed to the FDA’s prior post market authority. (And no, 1976 is not ancient history. Some of us actually remember it.)
Health IT is caught in the corn maze of promise vs usability and hazards. With quality design and thoughtful implementation the exit may be found before nightfall. Without it someone is going to have to call 911.
A recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users. The Times notes that these users may have a smart phone and laptop going at the same time they are sucking up streaming video. The high bandwidth demand of these devices, or more specifically, their uses, is said to be reducing download speeds back to the good old days of dial-up connections. A likely solution will be a tiered charge structure, similar to the newest cellular data plans, with the result that you can waste bandwidth if you don’t care what it costs. A more general report on current and future wireless demand versus capacity has been produced by the Global Information Industry Center at the University of California San Diego. A less foreboding report on medical uses of Wi-Fi has been produced by the Wi-Fi alliance.
Smart phones have a prior history of overwhelming cell phone networks, such that in dense environments someone can’t make a phone call because too many other people are watching reality show reruns and bad movies. Now some cellular devices have been looking at switching to Wi-Fi when it is available, as explained here. This leads to the conflict ridden situation of cellular wanting to use Wi-Fi to solve its capacity problems at the same time that Wi-Fi is being over loaded by other devices. Cellular resistant building structures, which are increasing, also can create a desire to shift to Wi-Fi.
Now think about hospitals. Tablets are surely making inroads here as well, along with smart phones and in house wireless VoIP. Medical devices are also increasingly wireless as has been noted in these pages before here and here. There is also the smart phone wireless app arena (which may or may not be regulated medical devices) as discussed here and here.
Certainly the public access side of a hospital’s wireless network can be limited and segregated. However prioritizing between multiple medical applications is far more challenging both clinically and technically. It must also be remembered of course that lost medical data or lack of clinical telephony can be life threatening, as opposed to merely annoying.
In this demanding arena few wireless medical systems are at least initially tested in a fully functioning environment. Yet there is a vast difference between whether the wireless capability (as well as the wired) is able to function when tested alone, and whether it is capable of functioning around the clock and throughout the year in an actual hospital when static and when roaming. In the latter case when roaming across access points, drop-outs may result in data loss and may not respond well when access is restored. While the link may recover critical information such as which patient is involved may not be available.
In addition it may be possible to add one wireless application today that works in the current environment, but which may not work when the next one or ten or 100 other wireless applications are added later, and perhaps not much later. In this regard vendor assurance, if ever fully believable, cannot be accepted outside the context of the wireless system and devices currently deployed. (By way of bad analogy, such an assurance are like a car salesperson telling you that with this car you won’t have to worry about highway traffic.)
In this regard the effective hospital application has been summarized as requiring ”assurance” which includes coverage, signal strength, capacity, and certainty. The “utility” analogy is often used here, i.e. the wireless service should operate in the background and be something I don’t ever have to think about, just give me more and more wireless devices and they will all play nicely together. (Those who have been through electrical blackouts and brownouts may have a different perspective than others on the reassurance provided by the utility analogy.)
It is clear that wireless and wired capacity have to both be actively controlled and monitored. Besides being totally logical, this is consistent with IEC 80001 (discussed here) which addresses hospital network risk management. This active control requires a centralized coordinator who has the authority, knowledge and system resources to not allow any new wireless application to be deployed without specific consent based on appropriately rigorous tests. There must also be complete inventory of all approved wireless users so there is a record of who is using the system. New systems or upgrade designs must also take capacity seriously (see here for example).
Certainly wireless, using Wi-Fi or otherwise, offers advantages in health care, although perhaps not, wireless will need to be limited to those applications that really need it. In any case, capacity is a challenge that is likely to get worse before it gets better.
Pictured above are Philips’ Intelliview Cableless Measurements wireless SpO2 sensors that use the same ISM band frequencies as Wi-Fi. This photo was taken at the Philips booth at HIMSS 2010 with their permission.
Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on their offer, I want everyone to understand that there’s not any favoritism that plays into who gets to post on this site. So, the following describes the ground rules, the benefits of contributing, and issues an open invitation to contribute posts.
We’ve been fortunate to have a number of terrific contributing authors over the years, and some of them have written posts that continue to be popular to this day. On the About This Site page is a long standing open invitation to anyone who wants to climb up on the soap box and
spout off contribute to the conversation about medical device connectivity. I’ve also made contributing author offers personally to many folks on both the provider and vendor sides of the table. There are so many people who have incredible knowledge and experience to share. And most of these people don’t have the time or inclination to create their own blog. Now you have an outlet.
Increasingly companies are adopting social media policies that establish ground rules for employees posting to blogs, Twitter, Facebook, etc. Besides benefiting your employer, contributing posts also benefits the writer personally with increased awareness and respect among your peers. Contributors also get an author’s bio like this one for current contributor, William Hyman:
Writers that want to remain anonymous can do so, to a degree. You can be anonymous like the blogger Tim at HIStalk. He doesn’t disclose his identity on his site, but he is not legally anonymous. This means that you can chose to not disclose who you are (or your employer), but if I’m legally compelled to disclose your identity I will. Some employers will appreciate this kind of anonymity because there’s little chance the writer’s opinions will be associated with the employer. Of course many employers, especially the smart ones, will want that employee-employer association to be known so that all the insight and intelligence the contributor demonstrates in their posts will rub off on them!
In the connectivity segment of the market, there are a lot of new entrants and many established companies flying under the radar of broad market awareness. Contributing blog posts about your experience or perspective (nothing too commercial please) is a great way to establish credibility and get the word out. The most effective use of blogging is engaging in a long term conversation with your readers. Most of my consulting business comes from this blog, in addition to the usual word of mouth and repeat projects. You put your content out in the blog, and readers come back with questions and requests for help with problems, advice, referrals to fill new positions, you name it. And I can’t tell you how rewarding it is to meet people at customer sites or events who are readers of this blog.
Unlike a magazine article, press release or white paper, contributing to a blog is typically not a one shot deal. A series of blog posts that address a body of topics or frames an issue gets read when it’s published – and after that – via search engine queries (that’s why it’s important to identify and use the right key words in your blog posts). Ideally, potential contributors will look at this as an extended conversation, or at least a series of posts that will span several months, if not indefinitely. Individual contributions are welcome, but they will have to be particularly thought provoking, entertaining and/or informative.
Why contribute posts to this site? Well, the site gets about 300 unique visits per day (less on weekends) and has hundreds of subscribers to the RSS feed (the funny orange square icon on the right). Readership is evenly split between providers and manufacturers. As a contributor you will get access to the sites statistics where you can see how many times your post is accessed and by who (or at least their IP address or domain name).
So, if you’re interested in contributing, let me know. And if you’re a reader, here’s your chance to leave some feedback – what would you like to read more or less of on this site?
As an aside, if you’re interested in the blogs and news sites that I read, keep an eye on the Connectologist’s Shared Items box in the right hand bar. This is a list of shared items from my Google Reader. If you’ve got a blog or news site to suggest to me or your fellow readers, leave it in a comment to this post.
[Flickr photo of Selma by Netzanette]
The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking for mischief, theft, politics, social protest and other forms and varying degrees of evil should surely come as no surprise. In turn, that a wireless medical device might be hackable should be somewhere on the mind of developers, users, and regulators. Thus the report from the recent Black Hat conference that someone hacked an insulin infusion pump, and in so doing was then able to alter its settings, should also not be particularly shocking, but should serve as yet another reminder, that security associated with connectivity has been and continues to be an issue, as was addressed by Tim back in 2006.
The report in this instance came from Jay Radcliffe who hacked his own insulin delivery equipment. In this instance the hacking avenue was the wireless remote that was part of the device. Perhaps the idea that a wireless remote could be emulated is even at the ultra low end of surprise. More generally, the multiple discussions of this report (e.g. here and here) have suggested that the technology being used by at least some medical device manufacturers does not offer an adequate array of security safeguards. Or the manufacturers haven’t fully utilized what is available in terms of alternate hardware, or they havn’t fully utilized the security features that were available even in the hardware that they were using.
Not surprisingly medical device manufacturers have downplayed the risks of hacking. The manufacturer of the pump in question, Medtronic, responded through a diabetes oriented web site, but apparently not through an actual press release of its own. The responses included that Medtronic does take device security seriously (would you expect them to say otherwise?), and that no real-life events have ever reported. Of course a problem with the later is that stealth hacking, as opposed to announced hacking, could cause harm while going unreported. This is to not say they have, but only to note that “reported” is a limiting case.
Medtronic is quoted further as saying “Our job is to incorporate information security measures into our designs, vigilantly monitor potential threats and to always be proactively finding ways to make our devices more secure for you. That is what we have done and what we will continue to do.”
A curious post in response to this expected response from Medtronic was “Security violations are caused by sloppy implementation. The systems themselves are very secure.” I’m not sure how much better that is supposed to make us feel. Equally curious was that this response referenced RSA as a security authority, with other posters then pointing out that RSA was itself hacked.
Hypothetically (that means I made up the following) assorted glitches and could-not-duplicate service events could be the result of hacking, i.e. if the hacker hacked, and then stopped hacking, whatever the effect of the hacking was could well stop also, and therefore be un-findable. Which reminds me of a hospital wireless interference anecdote I heard about bursts of interference, almost always during the night, and almost always for one or two minutes. The culprit was an old leaky microwave being used in quick mode. And why only at night? Because the cafeteria was closed then and therefore the microwave was a primary food resource.
The bottom line is that security is an ongoing issue that must be rigorously addressed by manufacturers, and in turn by the FDA who has to at least ask the what-have-you-done-about-connectivity-security, and insist on a firm answer. Further, I will ask the question that I asked about the challenges of hospital networking at an AAMI session last June in San Antonio. My question was, “Is the problem getting easier or harder?” The answer was a laugh.
[Thumbnail photo above (used with permission) shows the various sites used to inject insulin over a period of time - one month if I recall correctly. In the lower right corner is the Medtronic insulin pump dangling from a tube. - Ed.]