Bob on Medical Device Software

July-20-2014

2:25

I had been reading about “internet of things” (IoT) connectivity standards groups (links below) when I came across Bridget Moorman’s post Connectivity Standards Adoption Over Time.

I made an off-the-cuff comment because of the contrast I saw between the way other industries approach standards vs. the medical device industry.  Bridget and Tim kindly responded with informative feedback.

Standards are hard, so I guess it’s not easy for anyone.

 

June-3-2014

16:09

apple-healthkitThe reality of healthcare interoperabilty is going mainstream: Apple Launches HealthKit To Share Vital Stats With Nike, Mayo Clinic:

The problem Apple will run into: No one agrees on how to measure even very simple health metrics, …

TL;DR:  iOS 7.1 to iOS 8.0 API Differences (search for ‘HealthKit’ on the page).

April-6-2014

1:39

health-it-catagoriesThe Food and Drug Administration Safety and Innovation Act (FDASIA) required the FDA to develop:

a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.

Here’s the report: FDASIA Health IT Report (warning: PDF).

It looks like EMR/EHR vendors (administrative and health management functionality) don’t have to worry about FDA regulatory oversight. The medical device category (of course) does:

FDA would focus its oversight on medical device functionality because, in general, these functions, such as computer aided detection software and remote display or notification of real-time alarms from bedside monitors, present greater risks to patient safety than health IT with administrative or health management functionality.

 

March-25-2014

16:17

icu-interopThis is a good read: Healthcare Innovation Day 2014: Igniting an Interoperable Healthcare System (warning: PDF).

Healthcare is the one industry that’s been the slowest to adopt the intelligent methods we have in most other parts of our lives. How did the communications revolution that transformed industries such as banking, entertainment and telecom somehow leave healthcare behind?

Great question!

Here’s the ‘Call to Action’ list:

  1. Recognize that the lack of interoperability is a crisis and advocate for rapid change.
  2. Frame the interoperability problem correctly: Everyone is in the business of gathering and sharing data to best serve patients.
  3. Accelerate the full adoption of unambiguous, open standards for interoperability.
  4. Align stakeholder incentives to drive interoperability.
  5. Ensure validity, privacy, and security of data.
  6. Reduce technical complexity for hospitals, health systems, and healthcare workers.
  7. Develop new ways to use data streams that will result from interoperability to drive an adaptive system that will improve patient health.
  8. Guarantee secure access to data for patients, researchers.

There is a lot to do…

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