There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions.  These papers serve as examples of the active dialogue taking place around the appropriate regulatory framework for digital health solutions and the increasing awareness of the need to embrace rapid innovation while at the same time ensuring these solutions work appropriately for the patients that use them.

The first is a paper by Dr. Andrew Auerbach, UCSF Division of Hospital Medicine, Dr. Aaron Neinstein, University of California, and Dr. Raman Khanna, University of California, entitled “Balancing Innovation and Safety When Integrating Digital Tools Into Health Care.”  The paper proposes a “local evaluation” framework, which the authors believe “will likely replace formal evaluations” by the FDA, to ensure digitals tools are safely and effectively introduced into patient care at a particular institution or system.  Specifically, recognizing that digital tools “evolve rapidly” and are “unlikely to be supported by evidence from preclinical trials,” the authors propose forming “digital diagnostics and therapeutics committees” at individual institutions to evaluate and monitor digital health tools.  These committees would be modeled on existing pharmacy and therapeutics committees and would consist of groups of professionals with specific key competencies for analyzing digital tools, including information technologists and specialists in privacy and security.  The committees would be responsible for evaluating digital tools prior to and following local deployment to ensure patient safety, data protection and the feasibility of using the solution from a financial perspective, including by assessing the lifetime cost of the solution.  The authors suggest that local evaluation strikes the right balance between the need to maintain patient safety while encouraging and accommodating the rapid adoption of digital health solutions.

The second is a paper by Theodore Lee at the Yale Law School and Dr. Aaron Kesselheim from the Program on Regulation, Therapeutics, and Law (PORTAL), at Brigham and Women’s Hospital entitled “U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.”  The paper assesses the potential effects of the FDA’s Digital Health Software Precertification (Pre-Cert) Program and highlights the risk that, without modification, the program will “ascribe FDA validation” to digital health products “that have not established actual clinical benefits.”  The key issue identified by the authors is that “a company may follow best practices for internally testing software but still develop products that prove to be unsafe” and, therefore, the Pre-Cert Program’s reliance on the quality of a company’s internal processes as a substitute for the standard clinical study process is, in the view of the authors, insufficient.  Thus, while the authors recognize the benefits of the Pre-Cert Program and the need to expedite regulatory review of medical software more generally, they conclude that “safety and effectiveness standards for critical technologies cannot rely on manufacturer metrics over product performance” and that “adequate study of safety and effectiveness is needed at some point in [the product] lifecycle.”  The paper provides some data to back up its words of concern, including citing a study that showed only 12 of 117 mobile apps intended to treat depression offered support based on accepted standards of care and that even those 12 apps inconsistently adhered to the standards.  The authors are also somewhat critical of the Pre-Cert Program’s postmarket surveillance requirements and advocate augmenting those requirements with prospective trials and continual monitoring of real-world data.

These papers are good reminders of the need to balance the nimbleness and speed of digital innovation with the underlying objective of producing safe and effective products that provide real reductions in healthcare costs and improved patient outcomes.  The papers also illustrates a range of perspectives on the topic—highlighting how regulators, physicians, developers and legal professionals continue to grapple with these competing factors and foreshadow a future in which regulation is continually calibrated as digital health offerings evolve and the impact on patients becomes more readily discernable. As our Digital Health team recently reported, FDA is continuing with the Pre-Cert Program and Commissioner Gottlieb made significant announcements last month and released FDA’s first draft of a Working Model for the Pre-Cert Program.

Photo of Nigel Howard Nigel Howard

For over 30 years Nigel Howard has specialized in technology transactions such as M&A, strategic alliances, licensing, distribution agreements and outsourcing. Clients range from start-ups and emerging companies to international corporations. He has led negotiations of billion dollar service agreements that were critical…

For over 30 years Nigel Howard has specialized in technology transactions such as M&A, strategic alliances, licensing, distribution agreements and outsourcing. Clients range from start-ups and emerging companies to international corporations. He has led negotiations of billion dollar service agreements that were critical to his client, and successfully handled the intellectual property and data issues on over 250 venture capital and M&A transactions.

Nigel is a “tremendous attorney” singled out for his detail-oriented approach, according to clients interviewed by Chambers and Partners. Peer commentators note his admirable commercial awareness, which achieves business-focused results, often in the most challenging of circumstances. He uses his extensive experience with IP and technology to advise on the commercial imperatives underlying these agreements.

Nigel has been ranked by Chambers Global, Chambers USA, Legal 500, Best Lawyers in America, and Who’s Who in American Law. He is frequent speaker on AI, data, distribution, and technology legal issues. His past and current clients include American Airlines, the American Bankers Association, American Express, AstraZeneca, British Airways, Brown Brothers Harriman, Cathay Pacific, Cisco, CoBank, DoubleClick, Etihad, HPE, Farelogix, Iberia, Mars, Merck, Merrill Lynch, Microsoft, NCR, the NFL, Novartis, P&G, Philippine Airlines, Promontory Financial, Singapore Airlines, Teva, TouchTunes, UBS, and Wyeth.

Photo of David Wildman David Wildman

David Wildman specializes in complex transactions involving technology, intellectual property, and data. In this role, he regularly advises clients on issues relating to data commercialization, IP licensing, software development, and information technology services (such as cloud services, IT procurement, and outsourcing). David, who…

David Wildman specializes in complex transactions involving technology, intellectual property, and data. In this role, he regularly advises clients on issues relating to data commercialization, IP licensing, software development, and information technology services (such as cloud services, IT procurement, and outsourcing). David, who is a registered Patent Attorney and former electrical engineer, also advises on the intellectual property aspects of mergers, acquisitions, and strategic investments. David represents clients in a wide array of industries, including health technology, travel, and finance.

In addition to his broader practice, David is a member of Covington’s Digital Health Initiative. In that capacity, he counsels pharmaceutical, medical device, and technology companies on the complex commercial and intellectual property considerations that arise at the intersection of information technology, life sciences, and healthcare. These considerations include patient privacy and data security, ownership of data and derived insights, service levels, the development and exploitation of “Big Data” analytical tools and predictive models, and FDA-readiness, as well as other commercial issues that arise when entering into a partnership, collaboration or other strategic arrangement with participants in the digital health sector.

David also has extensive experience in the management and strategic development of patent portfolios in a variety of technical disciplines, which he leverages to help clients develop holistic intellectual property strategies that align to business objectives.

Before joining the firm, David worked at another leading law firm prosecuting patent applications in the U.S. and abroad, representing clients in post-grant proceedings at the United States Patent & Trademark Office (USPTO), conducting due diligence analyses, and rendering opinions on patent validity, infringement, and freedom-to-operate. David holds a degree in Electrical Engineering from Columbia University and obtained his J.D. from New York University School of Law. Prior to his legal career, David worked as a wireless design engineer in the mobile device industry.

Photo of Wade Ackerman Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade…

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.