I realize it's been quite a while since I taught - or was in school myself - but I'm distressed…
Morning Headlines 3/21/13
Transforming Health Care Through Big Data
The Institute for Health Technology Transformation publishes a report outlining strategies for health organizations planning to implement big data solutions. Among the major hurdles organizations will need to overcome are data fragmentation — the warehousing of data in disparate proprietary systems — and data usability issues resulting from key clinical information being captured in an unstructured form.
Recently launched health startup QPID raises $4 million in early fund raising, beating its goal of $3 million. QPID launched on St. Valentine’s day with aspirations of delivering an intelligent EHR search feature.
The Value of Medical Device Interoperability
Improved medical device interoperability could result in up to $30 billion in annual healthcare savings, according to a report released by West Health Institute. Joseph Smith, MD, chief medical and science officer, testified before the House Committee on Energy and Commerce about the findings during week-long hearings on innovation in health IT.
On Capitol Hill: FDA urged to clarify oversight of medical apps
Industry leaders from the mobile health market testified before Congress addressing the delayed publication of a final FDA regulatory policy over mobile health apps. The panel resoundingly concurred that the FDA should finalize plans quickly because the uncertainty is stifling innovation and funding.
It will be interesting to watch the impact (or lack there of) from the report on The Value of Medical Device Interoperability.”
At the 2013 Medical Device Connectivity Conference, West disclosed that they are working on a medical device interoperability solution of their own. Of course there are already 2 other initiatives in this area, the IHE’s Patient Care Device workgroup efforts, and the Integrated Clinical Environment spearheaded by Julian Goldman. It is not clear whether West’s effort will complement one of these, or strike out on their own.
The report itself seems a mixed bag to me: lots of good references and some interesting cost estimating, but ultimately the report feels like a piece of policy PR to be used in lobbying efforts rather than a sales tool to help buyers cost justify buying a particular solution. There are a lot of soft dollar savings that a hospital CFO would shoot down, but a policy wonk might accept.
RE: Congressional committee meeting on Mobile Health Apps.
How can a final guidance be late when there was no commitment as to when final guidance would be published? Typically, the draft guidance is not heavily revised in the final guidance, so mobile health app vendors should treat the draft as final, go with that and plan to do any regulatory backfill when the final version is released.
This is not rocket science, if your app meets the definition of a medical device, then man up and do the right thing. I can’t buy a new hot water heater for my house that wasn’t made under a quality system (ISO9001), why should an app to diagnose a disease or condition, or manage therapy delivery have a lower quality hurdle than my hot water heater? The FDA’s Quality System regulation is not much different from ISO9001.
Much of the reporting sounds like much of the session was atmospherics where Congress critters were trying to look like they were supporting their constituents against the FDA. Kabuki. High risk mobile health apps will be regulated, and down the road maybe medium risk apps too.
One thing that struck me is the elapsed times quoted that it took some mobile apps to get FDA clearance. Admittedly, there were a couple outliers. There was also a cost figure in the low $200k range quoted for one product to get clearance. The extra lengthy time and 6 figure costs are what happens when you don’t plan ahead. I would bet a nice dinner that both the long time frame and high cost were mostly incurred as the vendor was in “reaction mode” trying to figure things out as they went along. If you’re not a regulated company already, get some knowledgeable help; if you are a regulated company and this happens, well you screwed up.