Regulating Digital Health

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Publication Date:
September 2019
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As digital health progressively enters mainstream therapy, how should it be regulated and to what outcome?

Digital health is booming and as investment in digital health technology grows more products and services will be coming to the market—and that means more digital health for regulators to consider. Yet regulation is behind the curve and not keeping pace with the speed of digital health development. With a lack of clarity of what's required and an uncertain regulatory pathway, pharma and digital health developers need to fully understand the current state of digital health regulation and where it's headed to ensure their products comply.

As the regulation of digital health develops, all stakeholders need to closely monitor developments from leading regulators. That is why in, Regulating Digital Health, we interviewed leading experts to help you understand the current status of digital health regulation, its anticipated direction of travel and the steps you can practically take now.

Experts explore the emerging field of digital regulation

  • Which digital health technologies will need to be regulated and why?
  • Why will it be important to secure regulatory approval to bring a digital health product to the market in the future?
  • What are the issues for meeting privacy and security regulations for digital health?
  • How should regulators adapt their timelines to respond to the fast pace of digital health breakthroughs in the future?
  • The FDA is seen as being particularly proactive on regulating digital health. Which other regulators are taking a proactive approach?
  • Will post-market surveillance requirements increase in the future regulation of digital health and what are the implications for developers?

What our experts say…

"I definitely think securing regulatory approval in the future is going to be important to successfully bring digital health to market. It's like how a physician will buy into the idea of prescribing a certain medicine. They need to know it's been approved by a regulator. Then they need to know it's approved by working groups of physicians. In order for digital health technologies to get into the prescription pathway, I think the same thing needs to happen. The regulatory approval will be a key step in adoption or in accelerating adoption by the physician community. I am aware that there are a number of hospitals that have their own institutional review boards that actually approve or disapprove of certain technologies that can be used by their physicians in different departments. I think that's been a regulatory framework, but it's more hyper-local. You have maybe a physician group within a hospital vetting some of the solutions and deciding what they want to, and what they don't want to use."
Chandana Fitzgerald, HealthXL, Dublin

"Because of the adaptive nature of many digital health tools, the FDA and other regulators, will require developers and manufacturers to assess the ongoing safety and performance of these tools through the collection, evaluation and monitoring of real-world data and real-world evidence regarding the performance of the device. The FDA contemplates that developers will have to submit periodic reports to the FDA about broad aspects of the product's performance (e.g. user experience etc) not just adverse event data, which is a key focus of post market surveillance for traditional medical devices. Added to that, from an FDA perspective, any process implemented that would expedite the premarket review of medical devices would almost certainly be balanced with enhanced post-market surveillance of the safety and efficacy of those products."
Vernessa Pollard, McDermott Will & Emery, Washington DC

"It impacts the market; it goes both to the investor, and to where investors want to put capital into growing companies. If they're not likely to achieve revenue in a realistic time frame, or if the route to market is unclear, investors may be reluctant to commit. That means you may have lots of very good technologies running out of steam very quickly. Who's got the money to invest when there's an uncertain reimbursement environment or pricing structure?"
Sharon Lamb, McDermott Will & Emery, London

What to expect

  • A detailed report examining the development of the regulation of digital health products and the issues pharma and developers need to be aware of and plan for
  • An examination of 18 key issues which pharma and developers needs to understand and respond to
  • 11 targeted questions put to the experts
  • Their perceptive responses that provided 24 insights supported by 35 directly quoted comments

About the Expert contributors

The report harnesses critical insights and opinions from front-line industry experts who have:

  • Expertise on either the US or European markets
  • Relevant experience actively monitoring, working with clients and publishing on digital health regulation
  • Knowledge of current trends in the regulation of digital health

Anthony Barron, a Principal in the Life Sciences Practice of Charles River Associates (CRA) based in Brussels. CRA is a leading global consulting firm that offers economic, financial, and strategic expertise.

Sharon Lamb, a Partner at law firm McDermott Will & Emery, based in their London office.

Vernessa T Pollard, Partner at McDermott Will & Emery, based in their Washington DC office.

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