Washington, DC, is an impressive city. But too many times, one leaves our nation’s capital scratching one’s head. Understanding how large, complex agencies deal with equally large, complex issues is puzzling enough, but issues that change on an almost-daily basis—such as optimizing the potential of advances in digital health—call for much faster solutions than our bureaucratic system is designed to address.
To discuss ways to resolve the puzzles inherent in regulating digital health opportunities, Paul Sonnier and I met with Keith Studdard, the Legislative Director to U.S. Representative Marsha Blackburn (R-Tenn), who has been advocating a clearer, more streamlined regulatory approach to new developments in digital health. What was our reaction coming home? Instead of scratching our heads, we were pleasantly surprised by the level of engagement and dedication we found.
Our meeting included an acknowledgement that the Republicans in the U.S. House needed to address digital health regulations in a way that involved Democrats. Despite persistent accusations of partisan gridlock in Congress, I came away sensing a high degree of sincerity, at least judging from the candid remarks coming from Blackburn’s office. One of the biggest problems to legislators and regulators in digital health is uncertainty within the industry, a point Studdard reinforced by citing the old maxim that, while “no” is often an answer that people don’t want to hear, “maybe” is worse, particularly in terms of its impact on business planning. And at the moment, digital health’s regulatory future is replete with “maybes.”
Blackburn has been involved in regulating digital health for at least two years, when a Memorandum of Understanding (MOU) was signed between the Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) to help eliminate the “maybes” and coordinate regulations of mobile health apps, devices and other innovations in digital health. The FDA and FCC agreed that wireless and digital health is a brave new world and admitted they were not equipped to deal with this fast-moving area. The agencies admitted that no policies that existed in 2010 could be written in such a way that comprehends what the mobile health space would mean for consumers or patients. The MOU promised to focus on this.
Blackburn was one of six members of Congress who recently crafted a letter asking for a progress report from the FDA and FCC on this MOU. What should be regulated? How should they determine what gets regulated? What regulations would apply? What’s happened since the signing of the MOU in 2010?
Certainly, patient safety, medical record security, and consumer protection are very important areas to consider from a regulatory perspective. But how much regulation is necessary? And how can these regulations provide safeguards without slowing innovation? What types of regulations do you think are necessary in this area? And how would they keep up with the ever-changing digital health world? Let us know, and we commit to continue engaging with those – like Mr. Studdard – who can help make a difference!
Tags: cyber health, digital health, digital technology and health, health technology, Keith Studdard, Marsha Blackburn, U.S. Congress
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In a recent Forbes article on the last FutureMed meeting in California, writer David Shaywitz expressed his concern that technology developers are more focused on their technology than with how it may be accepted by health care practitioners. But he also expressed hope that, soon, technology and the practice of health care might experience a meeting of minds (and possibly even hearts).
At Popper and Co., we make an effort to search for technology solutions that can truly make a difference in health care, and often we’ve been skeptical of the “latest shiny new thing.” While I believe that sometimes technology apps appear to be solutions in search of a problem, we are arriving at a point in time when a happy merger between health care and health technology may be feasible. Why?
- Because we (the scientific and technology community) now understand enough about biology to adapt technology to address real clinical problems. Our knowledge of genetics alone allows us to design targeted (i.e., “personalized”) therapeutic solutions.
- Because cost and resource constraints have led to patients being more engaged in the price and quality of their health care.
- Because consumer power has forced many practitioners (and technologists) to consider the “might” of this market.
- Because new technologies facilitate fundamental health service innovation for providers as well as patients.
In response to a related article by David Shaywitz, Popper and Co. strategic advisor Paul Sonnier had this to say:
While we need to be cautious about broad generalizations when it comes to digital health (which includes non-FDA-regulated consumer solutions) and the business sectors where it is having a direct impact, drug development – an area of focus in Mr. Shaywitz’s Forbes piece – is certainly seeing the integration of wireless technologies in a beneficial way. For example, new, “virtual clinical trials” enabled by smartphones and other apps allow patients to register and participate in drug trials without visiting a clinical site. Moreover, monitoring clinical trial participant compliance and relevant vital signs via wireless health devices can provide a greater level of detail and confidence in study data and conclusions, which is also of benefit in obtaining FDA clearance. DNA sequencing, too, which has been described as “bio-digital health,” allows for more targeted clinical trial participant selection and a movement away from population-based medicine. These examples alone illustrate digital health’s potential to improve biopharma’s bottom line and, ultimately, create better, more individualized health care.
Finally, here are some thoughts on the topic from Popper and Co. co-founder Ken Walz:
Many new emerging technologies have disruptive potential; including smart phones for clinical trials, remote diagnosis and data interpretation, for example. And there are some areas of health care in which patients and practitioners may be more amenable to adopting new technology. But not every part of medical practice is welcoming technology with open arms. It’s important to note that many of the areas that aren’t as accepting happen to be the more challenging areas of medicine. To assess the fate of all technology based on its current lack of proven utility in specific niches of health care may be setting the bar needlessly high.
In fact, targeting areas that are less “sexy,” but nonetheless important—e.g., process workflow improvement, better use of sensors, remote monitoring of patient compliance, and online appointment scheduling and lab result access—could deliver a great deal of value through new technology adoption.
Where do you see the most ideal matches between technology and health care? What challenging areas of medicine might be better postponing marriages with technology for another day? Do you have specific questions about the convergence of technology and health care that you’d like to pose to us? Share with us here.
Tags: bio-digital health, cyber health, digital health, digital technology and health, health technology, healthcare technology, telemedicine
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