Friday, June 16, 2017

The FDA promises a path forward, in digital health and other areas...

I find it quite interesting that, just yesterday, I had complained about how the FDA and other regulatory agencies are behind the curve on cyber-security, and today, at least with regard to digital health, the new FDA Commissioner Scott Gottlieb is promising some key changes and efforts going forward. This is, to say the least, heartening to hear, especially since at least some of the efforts continue on from the previous administration and that is a good thing. Not only do we get continuity, but also rapid progress as opposed to a back to the slate approach. I only hope that in the long run, the FDA stays guarded against haphazard deregulation, the kind that eventually caused patient injury and sparked anger and intense debate in 2007. I also want to remind everyone that the FDA has only provided forward looking promises, and only when these things come to fruition would a better picture emerge.

Most of the information, comes directly from a blog post by Scott Gottlieb (that quite irritatingly leaves out the definite article when addressing the FDA throughout the post). The post is linked below, along with an article from CNBC with some caricatured, over the top reactions. I wanted to discuss a few, salient points here.

The Stratified Regulation of Digital Health

When it comes to digital health, things have been haphazard so far. Some organizations decided by themselves that regulation did not apply to them. Ever guarded about their role, the FDA stepped in and refused to simply give up. Then came the uproar about what should and shouldn't be regulated. As Gottlieb points out, the 21st Century Cures Act rids the FDA of the need to act on simple applications, such as healthcare lifestyle/motivational mobile apps and administrative software programs. This is a great step forward. However, for example, blood glucose monitors and accessories, pictured above will continue to be regulated (in the past, poor design decision making led to patient death and a company shut down).

Clinical Decision Support (CDS) Software

Clinical Decision Support Software programs, either by themselves, or in conjunction with medical devices will provide recommendations for diagnoses, treatment, dosages etc. As such the FDA has regulated them without guidance and this has led to much stress and discussion. There has been a long, ongoing effort to try and make some clarity available, and it appears that the FDA is finally promising (mind you, that is all we have as of now) that this will happen. What exact shape and form this will take is unclear as of now.

Something, Something, Opioid Crisis

The opioid crisis is real, and action is necessary, but from Gottlieb's writing, it is unclear what the FDA will do. Past contests and prizes are great, but if they plan to do something more concrete, I was not able to glean any of that from the blog post.

Pilot Programs and Cutesy Abbreviations

So today, through Gottlieb's blog post, I was introduced to a new term - Software As a Medical Device (SaMD). Apparently, a third party certification agency will allow low risk devices to be "per-certified" and marketed without FDA pre-market review, and high risk devices will be undergo an FDA review. Who will do this classification is unclear from the blog post, and frankly worries me. Information on an apparent pilot underway to accomplish this is also thin on details.

On Third Parties and the Risk Based Approach

Terms such as "third party certification agencies" make me a bit squeamish. Almost never in the open, but heavily so in private, Regulatory Professionals in the Industry writhe, squirm and complain about how the third party certification agencies that oversee CE Marking wreak havoc on their day to day jobs. Privatization is always a mainstay of the GOP agenda, but it is very disconcerting to see this discussed in the context of regulation. One fundamental qualifier for the FDA has been that, holding devices, software, pharmaceuticals and much more to a very high standard has proven quite (safe and) effective for those of us here in the US. I wonder, if the pilot, is but a pilot to extend this "third party" business into other areas that come under FDA purview.

Sure, it is good for businesses and a new crop of companies and consultants it will foment, but is it good for the US consumer in the long run? My answer is - NO!

I don't understand why the FDA would have difficulties doing the classification and the consequential pre-certification. This is something that gives me a long pause, but let's wait and see how the pilot pans out and what comes of the actual efforts at guidance and regulation after.

Over all, medical device and pharmaceutical companies already consider a risk based approach in design and manufacture and the FDA also encourages this. This part, I like. It is important to focus on critical, high risk items that have bigger impacts and not on the minor details.

National Evaluation System for health Technology (NEST)

This was fun to learn about. Through the Medical Device Innovation Consortium (MDIC), post market data is apparently to be made available to engineers and designers to improve product design, by 2019. This is quite interesting and exactly the kind of innovation that SHOULD be outsourced to "third parties" and made available to all. You wont hear me disputing this one.


Scott Gottlieb's blog post appears to be well thought out. It makes promises, most, if not all of which appear lofty and beneficial. However, as I have mentioned previously, these are just onward looking statements and only time will tell how they all play out. So, I would advice everyone to take a more measured approach and wait for more concrete information to emerge.


1. Scott Gottlieb's Blog Post:

2. An unjustifiably jubilant CNBC Article:

3. A cool Fiercehealthcare article on CDS Software Regulation Guidance:

4. Image, Courtesy Pexels:

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