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.
Drummond Group’s ONC-ATCB EHR Program
Problems viewing the HHS Certified Health IT Products Listing?
Please go to http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204
Home page of healthit.hhs.gov and look under “What’s New”
Questions? Shoot us an email at EHR@drummondgroup.com
The Kennedy-Dodd bill would create an individual mandate requiring you to buy a “qualified” health insurance plan, as defined by the government. If you don’t have “qualified” health insurance for a given month, you will pay a new Federal tax.
Take all the things that are off about US healthcare, ignore them, and heave a corporate subsidy into place as a solution.
Those who keep themselves healthy would be subsidizing premiums for those with risky or unhealthy behaviors
force patients to accept what a bureaucrat deems “proper” healthcare regardless of what the patient deems proper care
I’ll leave it to you to decide for yourself how well your country manages this issue, whether you’re happy with the way the case-by-case decision is made, whether it’s going to be the immoral or the distasteful for you and your loved ones.§
“It's important to ask this question, because this is precisely the situation where the Canadian-type health care system -- much touted by reform advocates -- tends to fail Canadians.”Yes, the Canadian government makes one set of decisions. These weight some situations preferentially over others. And then:
“In the United States if someone falls and hits her head and then an hour later is rushed to the emergency room you can bet she will get a STAT CT scan and immediate neurosurgical attention.”This is another set of decisions. Because there’s a word or two missing from this paragraph – this doesn’t apply to all citizens, only to those with “coverage” – a number steadily decreasing at this time. Both of these are two-tier systems. The Canadians just outsource their first tier to USA – works well for everything but emergency medicine.
Daschle wants Americans to host “holiday-season house parties to brainstorm over how best to overhaul the U.S. health-care system,” the WSJ reports.
There is no question that the economic health of this country is directly related to our ability to reform our health-care system
The Health IT Nerd has spies all over Europe, so I got showered with notifications when a new report was released by the EU last week.
These reports are nothing new. Governments need to commission these reports every so often, to make sure that they’re not on track in their programs. And it doesn’t matter which government, it always works the same way. The government announces it wants a report, and invites all and sundry to bid to do it (usually this is called and RFP or something similar). Then the government ranks the bids, and either picks the one it was going to pick anyway, or chooses the cheapest, from the dumbest least informed clown that bothered to respond.
If it was a pre-selected winner, then, surprise: the report spins things how the government wants. Or, if it’s the cheapest respondent, then the report might say anything at all. If it’s sufficiently crap, the government throws it to the wolves (whoops, I mean the relevant industry), and everyone feels better for having canned the crap that the government needed canned anyway.
This happens everywhere in every industry. I think it gets taught in Government 101. But everyone plays the game dutifully, because you never know quite which variant of the game is on until later. Hindsight is 20/20 (or maybe just 20/10 or something).
In spite of that, I’ll bet all the monopoly money I can find in my hovel that this one is being thrown to the wolves. One thing you can be sure of: it’s utter crap. Check the extensive and thorough preparations undertaken to prepare this report:
In November 2007, empirica conducted an online survey of e-health experts from ICT industry, user organisations, public authorities, university and research, SDOs, and consultants. 94 experts responded
94 experts? Wow, that’s thorough. For all we know, 90 of them were French, and the French don’t know anything about anything. Also, it lists OpenEHR as a standards organization. Now while the openEHR guys seem to be trying to do something useful, they ain’t no standards group (actually, I think I'll make a report of my own about them in the future).
If I hadn’t already had turkey for thanksgiving, this report would’ve done nicely for a late consolation prize.
So, let’s see what their extensive research yields in terms of conclusions:
Current situation in e-health standards: Nearly all interviewees agreed that there is a lack of widely used e-health standards.
There’s a lack of widely used e-health standards? Have they not heard of HL7? Or perhaps “widely” has a different meaning in Europe? So maybe the respondents were French after all.
Impacts of current situation: Nearly three quarters of the respondents indicated that within a single health service provider the overall situation is supportive, but the majority found the situation unsupportive for cross-border care provision.
Barriers to adopt common e-health standards in hospitals: Hospital IT managers may first of all find internal process functionality more important than commonly used standards.
Hang on: “waste money on standards”?
Isn’t the whole point of standards that they save money? Well, yes. And no. Rather more no than yes, unfortunately, in the healthcare industry. If everyone adopts standards over the industry as a whole, then they will pay off. But only if everyone does. It’s a two-edged sword.
For vendors, in the absence of standards, they get paid to do the same work again and again – nice safe money. But that sucks. No one enjoys it, and it’s damn hard to hold on to staff as it is without making them do the same thing again and again. For care providers, adopting standards might offer the ability to purchase cheaper software, but it also means behaving in a standard fashion. Where’s the business ego differentiator in that?
If you look across other industries, and see which ones have rapidly adopted standards, it’s the ones where the adoption of standards has drastically increased the size of the whole pie, so everyone benefits. But in health, the pie is already as big as it can get. So the result of using standards is just to reallocate parts of the pie.
It’s not for lack of trying, but the governments can’t impose proper standards on the industry, because the industry just doesn’t want them across the board. It’d rather adopt them in a piece meal fashion – the patient will pay, one way or another.
And how can healthcare get away with this? Politics. It’s always politics. See, doctors have unbelievable power in society, and they’re tremendously conservative when it comes to how things are done. Sure, that’s got it’s bad side, but hands up anyone who wants to volunteer to be the guinea pig for a new way of doing things. And everyone, even El Presidente or whatever they’re calling themselves this year, eventually everyone is going to be a patient.
Anyhow, back to the report. It seems to me that they demonstrate a complete knowledge of the current state of the industry when they say:
In January 2008, the US Department of Health and Human Services recognised certain interoperability standards for health ICT which federal agencies have to include in procurement specifications for certain fields of health. This could be a step towards mandatory use of a confined number of standards for principal e-health applications. Such a regulation by the US government could have considerable impacts in the EU. In order to prevent unfavourable developments, the EC and the Member States may be well advised to develop a common strategy and roadmap for e-health standards development.
Interoperability: it’s all about the people. And it doesn’t look like there’ll be any change soon.
IT is the great white hope for healthcare, the healthcare administrator’s wet dream: we’ll be able to reduce the cost of this monster using IT and improve service at the same time. And like all fantasies of this type, what you get in the cold light of day just isn’t quite the same – that sensuous young woman turns out to be a withered old hag with a sour disposition (or, for my female readers – if I still have any: that buff young man turns out to be a crotchety old jerk with a hairy back).
One of the principles is easy to grasp. Anywhere between 50% and 80% of healthcare professionals’ time is spent tracking down information so they can provide proper healthcare. That’s right – that doctor who’s getting paid a million smackers a year: he spends most his time finding the right pieces of paper. That's not all - almost all of the preventable deaths that occur relate to missing information one way or another.
So, if you stick all that information on computers, and they can talk to each other, then the information will just be right there, exactly when and where the healthcare professional needs it. Magic! And we could get twice as much work for the same amount of money, and with less “totally negative health outcomes”. So you can see how seductive this idea is – up there with the supermodels. Also, see the Turkey I had for thanksgiving.
Actually, it would be magic if it worked that way, but the real magic is in the innocuous words “they can talk to each other”. In the healthcare IT industry, this is called “interoperability”, and it’s the Holy Grail. It bears startling resemblance to the Holy Grail too. Not only has no one ever seen it, we don’t even know what it actually is.
I’m not so sure. I’m married, and I know that once you understand each other, you no longer need to talk anymore. Yeah, yeah, everyone laughs when I say that, and pities Mrs. Health IT Nerd. And I mean, I understand their pity, because I know me even better than they do, but they’ve missed the point: Mrs. Health IT Nerd and I are never going to understand each other (any of you that are married will know exactly what I mean). So our lives are full of interesting times, and we are forced to keep talking to each other.
So this is what makes interoperability so much fun: we’re never going to understand each other fully, but we have to get along anyway. I think this is one of the craziest things that happens in health IT, that the industry so seriously misunderstands what will enable interoperability, and what the results might be.
Classic interoperability theory says that in order for two computers to talk to each other, you need the following things:
It’s the same requirements for humans to talk together, on any scale, from my two small kids arguing about who gets to be the doctor and who is the patient, to diplomats from two large countries resolving which side of the border their soldiers will get to acquire their need for emergency healthcare on.
Actually, that stack above is incomplete. There’s something else that most interoperability wonks don’t stress, but I can’t stress enough:
Like Mrs Health IT Nerd and I, no one knows how to even agree on what this “context of operations” thing is, how wide and deep it is.
Take a simple case: in Isaac Asimov’s Foundation, one of the characters says: “Violence is the last refuge of the incompetent”, by which he means, only the incompetent will use violence because it doesn’t solve anything.
Well, I have a friend (Yes, I *do* have one), and he’s a wingnut, so he says that this means that competent people would have resorted to violence long before it’s time for the last refuge. While that interpretation is the polar opposite of the one that was intended, the actual words and the grammar are understood the same way. It’s the different background values people use when evaluating the meaning of the phrase that make the difference here. (Which interpretation is correct? It’s not like it matters for this column, but I figure that what happened in Iraq - or any other war - shows the statement is wrong and stupid however you want to read it.)
This is why interoperability is so hard: there are so many layers to understanding. A whole industry exists to define interoperability based on standards that provide meaning for that stack, a whole alphabet soup of them, such as HL7, CEN, ISO, IHTSDO, ASTM, ANSI, WHO, W3C, OASIS, WS-I…. a never-ending profusion of standards bodies. You know what? These standards bodies, these definers of interoperability, they can’t even interoperate amongst themselves, so it’s the proven-blind leading the probably-blind.
These standards are all going to fail. Well, not so much fail (though it might be best if, umm, if we all don’t actually look too closely at them when we say that), as not quite deliver all the things people are demanding from them – just small things, like life, the universe, everything, and also world peace as well. These things won't happen, but there will be some outcomes: life will get better, healthcare will improve. But you know should know by now what happens when healthcare improves: costs go up; so even if these interoperability standards deliver everything anyone dreams of, the outcomes won’t be what they desired in terms of cost-cutting.
Even if the healthcare administrators and those who pay for healthcare (i.e. you!) scale back the expectations of what interoperability can achieve to something reasonable, these standards are not going to deliver, because they’re all based on the expectation that if you solve the technical problems, interoperability will just happen.
It’s people who insist on doing things differently, calling the same thing by different names or vice versa. It’s people, who, given the same patients, the same healthcare problems, and the same computer systems, find completely different ways to achieve roughly the same outcomes. And for all these people – both healthcare professionals, and healthcare informaticians (horrible word!): there’s my way of doing things, and all the wrong ways to do it. There’s even a step beyond that, people for whom there’s my way of doing something, and all the other ways that I am dedicated to destroying. These people are methodological terrorists, and they are attracted to standards. This is part of why the healthcare standards wars are such fun.
So the fundamental problem of interoperability, of getting the information to the right person at the right time, is the first and last steps – getting it out of the first person who has it, and into the other person who needs to understand it in the appropriate context, how it relates to all the other information they have. Compared to these two problems, everything else is just plumbing, though we can’t even get that right. Interoperability is about people, not technologies.
Perhaps the healthcare industry isn’t so stupid to spend below average amounts on IT after all.
However we’re clearly going to spend what we do have on chasing the chimera of getting computers to fully understand healthcare – that is, us. Well, that will never happen.
So I think that we need to start focusing on enabling interoperability without trying to understand each other. See, if we all focus together on trying to achieve something perfectly useless, there’s a reasonable chance that we might actually succeed, especially since we've already achieved one of the desired outcomes – we’ll never understand each other.
| Healthcare IT, also known by the acronym HIT, is all about using information technology solutions such as hardware, networking, and software to help improve healthcare, save lives, reduce costs, and improve profit margins for healthcare organizations. Healthcare IT has always been important but recently it has been receiving more attention because the government and consumers (patients) | are demanding better service from care providers and healthcare IT is a good way to improve service.The healthcare system, especially in the USA, has some critical problems such as nurse and physician shortages, spiraling costs, poor consumer (patient) service, and lower revenues which lead to mergers | or acquisitions. Healthcare IT is in even worse shape because outdated infrastructure, legacy architectures, and monolithic applications prevent positive change from occurring. Healthcare IT can, if used properly, help reduce costs, improve care provider productivity (which can then alleviate some of the shortages), and significantly improve customer service to patients. |
