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.
Health IT Risks
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.Read More
On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps. Thoughtful comments by David Doherty and Nathan Billing in a LinkedIn discussion prompted the following. My imperfect interpretation of their comments was the impetus for this post.
David suggests that FDA regulation will stifle mobile app innovation, and observes that brand-name phone manufacturers are in a better position to shoulder FDA regulations than startups. He further wonders why an App Store that takes a 30% cut of app revenue does not appear to draw any regulatory attention from FDA.
Nathan agrees that over-regulation could stifle innovation and suggests that the regulatory burden should vary based on the intended user. Nathan implies, I think, that apps for health care professionals should face greater regulatory scrutiny than apps for use by patients. He also laments that FDA has not designated specific standards that would facilitate cross-vendor interoperability in the mHealth ecosystem.Read More
As medical applications for mobile devices have proliferated, regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those, which will the FDA focus on for regulatory action. To date these apps range from home use adviser’s, guides and “toys”, which may or may not have real health care implications, to serious medical devices which have clear health care functions, despite in at least some cases, pretending they do not really, perhaps in an attempt to avoid the FDA.
On July 19, 2011 the FDA announced its proposed official action in this regard, including defining “mobile medical applications” that are the subject of this action. (I will use the acronym MMA, although the FDA did not.) . This includes a new FDA web page for mobile apps (here), with links to a new Draft Guidance, information for consumers, and a press release. This action by the FDA has a parallel to the recent final rule on Medical Device Data Systems (MDDS), discussed by Tim here, which also addressed what is it, what is it not, and how that which is will be regulated.Read More
This new report (download page) is focused on the factors that contribute to effective home health care: integrated and easy to use medical devices and information systems, and the physical characteristics of a home that is supportive (or at least does not present barriers) to home health care delivery. There is quite a mix of recommendations in this report, from the insane (numbers 6 and 7) to the most excellent (numbers 4 and 9).
I came across this via a Modern Healthcare blog post by Joseph Conn. Like me, Conn was drawn to the first recommendation (from the NRC report):
Recommendation 1. The U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology should collaborate to regulate, certify, and monitor health care applications and systems that integrate medical devices and health information technologies. As part of the certification process, the agencies should require evidence that manufacturers have followed existing accessibility and usability guidelines and have applied user-centered design and validation methods during development of the product.
I have an opportunity to conduct a post-conference workshop at this year’s Healthcare Unbound conference. This year’s event is in San Diego, July 11-12 at the Manchester Grand Marriott. The title for the workshop is, Developing a Regulatory Strategy for Your Healthcare Unbound Product. The workshop will be conducted the afternoon of July 12th. You can read the workshop description at the end of this PDF document.
The rationale behind the workshop is the need to clear up confusion on the part of many product developers regarding regulatory issues like,
- Is my product a regulated medical device?
- What does it mean to be regulated?
- If I don’t want to be regulated, can I avoid regulation – and if so, how?
Ideally, we can structure the workshop around attendees actual products and situations. This, of course, will depend on folks registering in advance with sufficient lead time to actually prepare some content around their unique situations. Using participant’s products as case studies should be more engaging and relevant for everyone. If you’re registered for the workshop and want to provide a case study, let me know by completing this contact form.Read More
I’ve been getting a lot of questions about this. Here’s the latest:
I am hoping you can answer this question for me. Would [redacted company name] a data storage company come under the MDDS final Ruling? Are hw/sw services all types of companies including medical.
Unfortunately, where the FDA is concerned, very little is black or white. Short to-the-point questions usually don’t result in meaningful answers.
One unambiguous issue we can get out of the way is that the FDA regulates products through their regulation of manufacturers. All regulatory questions revolve around the product, but it is the manufacturer of the product that has to jump through the regulatory hoops. A manufacturer may chose to have one set of policies and procedures that conform to the FDA regulations for their medical device, and another for unregulated products.Read More