Vital Signs: Digital Health Law Update | Winter 2020

Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital health. We plan to issue Vital Signs near the beginning of each quarter to cut through all the noise and provide access to a curated resource on "must know" legal and regulatory topics impacting digital health.

As you will see in this first issue, our team of contributors from around the globe culled through various information across legal specialty areas (cybersecurity, health regulatory, IP, litigation, tax, and transactional) to present complex issues in a user-friendly fashion. Hot links to underlying legal and regulatory materials are included within each section, enabling Vital Signs to serve as your ongoing quick reference for all the notable recent legal and regulatory materials.

In this issue, we start with "Industry Insights"—dedicated in each issue to an overarching topic of industry interest—covering the evolving nature of how disparate industry stakeholders are advancing their vision, collaboration, and utilization of digital health, especially in the decade ahead. You'll also learn about: (i) U.S. federal efforts focused on streamlining FDA's digital health approach and advancing Medicare's telehealth reimbursement, while enforcement attention and methods evolve; (ii) U.S. states' legislative attention around telehealth and data privacy; (iii) Europe's flurry of digital health policy covering privacy, cross-border services, device development, and interoperability; (iv) Mexico's adoption of a novel tax on digital intermediaries supporting telemedicine; and (v) Japan's adoption of significant modifications to its Pharmaceuticals and Medical Devices Act.

INDUSTRY INSIGHTS

Worlds Colliding—A New Decade for Digital Health

By Maureen Bennett, Ian Pearson, and Laura Koman

Over the past decade, unprecedented advances in technology and know-how have resulted in an ever-expanding and diversified "digital health" universe. From the growing use of communication technologies to deliver clinical care, to the rise in fitness and healthy living apps, to improvements in diagnostic medical devices, digital innovation has increasingly defined many of our health care experiences over the past 10 years. As we enter a new decade, it is certain this trend will continue.

We expect the next 10 years, however, to encompass something more than continued vertical growth. If the last decade was defined by innovation and forward advancement in numerous yet siloed sectors of the health care industry, the next decade is likely to be defined by horizontal growth—a growing overlap in disparate digital health worlds to create one, integrated digital health ecosystem. We began to see some of this overlap at the tail end of the 2010s.

For example, traditional telehealth services are starting to incorporate medical devices (particularly diagnostic and triaging software) as part of patient-facing platforms. Software has long been used for administrative functions in health care settings. In the last few years, however, we began to see new types of clinical decision support ("CDS") software being utilized for things like patient screening, as well as for assisting providers in identifying the most appropriate treatment plan for a patient's disease or condition. To date, these functionalities have been relatively simplistic, but with the rise of machine-learning algorithms and AI, it seems certain that more sophisticated medical software will soon be upon us. We anticipate that CDS software will become a ubiquitous and indispensable aspect of patient care in the 2020s.

Digital health is also being utilized to bring therapies to market. Sponsors of clinical trials increasingly use digital means, such as data mining through claims and electronic health records, to more rapidly and comprehensively identify, recruit, and engage with clinical trial participants. The use of wearable technologies has also improved the means of collecting and transmitting clinical data to trial investigators. Together with the more traditional means of communicating patient reported outcomes, the use of data from wearables enhances a sponsor's ability to demonstrate the achievement of applicable clinical trial endpoints. In addition, technological advances are being further deployed to support the development of "decentralized" or "virtual" clinical trial protocols, in which an increasing percentage of trial procedures are administered from a patient's home or other remote locations.

The promise of digital health in each of these contexts is significant. These developments could result in less expense, more expedient and more accurate outcomes, and better engagement with subjects, patients, and consumers. But these developments, of course, also give rise to attendant practical and legal challenges, particularly given the different rules and regulators involved. For example, the use of sophisticated medical software and data mining gives rise to privacy and security concerns and may require the use of special informed consents. Likewise, while clinical trials are typically regulated at the federal level, the rise in "virtual" clinical trial protocols may require careful consideration of state telehealth and practice of medicine rules. While the development of technology invariably lurches ahead of regulation, all stakeholders will need to work together to advocate for continued evolution of the regulatory process to allow for a responsible deployment of innovative technologies to improve patient care.

UNITED STATES DEVELOPMENTS

Federal

FDA Proposes New Guidance on Clinical Decision Support ("CDS") Software

In 2016, the 21st Century Cures Act ("Cures Act") explicitly excluded CDS software from FDA regulatory authority. Due to the impressive diversity of digital products that provide some type of clinical decision support (including many that incorporate artificial intelligence and machine learning algorithms), industry stakeholders have since grappled with significant uncertainty about whether certain applications might qualify as CDS software or, alternatively, fall under FDA's regulatory authority. FDA initially issued draft guidance in 2017 to help resolve some of this uncertainty but later withdrew that draft guidance in response to public feedback. FDA recently issued new draft guidance in September 2019 to again address the lingering uncertainty. The September 2019 draft guidance identifies three distinct categories of software: (i) that which meets the Cures Act definition of "CDS software" and, therefore, falls outside of FDA regulatory authority; (ii) that which falls under FDA's regulatory authority but over which FDA intends to exercise "enforcement discretion" due to the lower risk of the applications; and (iii) that which falls under FDA's regulatory authority and over which FDA intends to focus its regulatory oversight. Industry should closely monitor FDA's oversight activities with regard to CDS software in 2020 to gain further insight into FDA's interpretation of its regulatory reach.

FDA Modernizes Regulations to Facilitate Utilization of Digital...

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