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.