Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on their offer, I want everyone to understand that there’s not any favoritism that plays into who gets to post on this site. So, the following describes the ground rules, the benefits of contributing, and issues an open invitation to contribute posts.
We’ve been fortunate to have a number of terrific contributing authors over the years, and some of them have written posts that continue to be popular to this day. On the About This Site page is a long standing open invitation to anyone who wants to climb up on the soap box and
spout off contribute to the conversation about medical device connectivity. I’ve also made contributing author offers personally to many folks on both the provider and vendor sides of the table. There are so many people who have incredible knowledge and experience to share. And most of these people don’t have the time or inclination to create their own blog. Now you have an outlet.
This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event dedicated to medical device connectivity.
Since last year’s conference so much has come to pass:
- The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions.
- The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy.
- The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors.
On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps.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
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.
After missing last year’s meeting in Tampa, I’m back at AAMI – one of the two events that I try to attend every year. The focus on connectivity has increased as there is a full track devoted to the topic this year.
One change this year, is that my blog posts from the conference will be appearing on the Medical Electronic Design magazine blog, found here. As usual, I’ll also be taking lots of photos, some of which may also be posted on the MED blog. Eventually most all the photos (the good ones that aren’t confidential) will be posted on my Flickr account, here.Read More