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.
The 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).
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.
This 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?
Here’s the ‘Call to Action’ list:
There is a lot to do…