Recently, the Connected Health Initiative (CHI) sent newly-appointed U.S. Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn a welcome letter outlining CHI’s current advocacy on digital health regulations before the agency. Commissioner Hahn joins FDA at a critical time for furthering use of connected health tools and has a fantastic opportunity to continue the agency’s leadership on these issues.

For years, CHI has worked with FDA to improve policies and processes through key guidance documents and proposed regulation. We have long recognized that FDA’s approach to emerging technologies will continue to influence the wider healthcare ecosystem that is shaping new coverage policies, developing clinical practice guidelines, and pioneering new software-driven medical tools that save lives.

Below are the recommendations CHI sent to Commissioner Hahn to provide a pathway for the wider use of connected health tools by clinicians, ultimately benefitting millions of patients across the healthcare continuum.

Protect Patient Safety and Improve the Medical Device Regulatory Process

CHI commends FDA’s risk-based approach to the regulation of medical devices. Specifically, CHI applauds FDA’s use of enforcement discretion for low-risk devices. We support the FDA in pursuing any and all opportunities to modernize and streamline the medical device approval process, particularly for software as a medical device (SaMD), as well as medical devices that utilize software and internet connectivity.

For example, CHI recently shared comments with FDA on the Clinical Decision Support (CDS) Software Draft Guidance. CHI supports FDA’s attempt to clarify CDS but offered substantive feedback on the agency’s reliance on the International Medical Device Regulators Forum. We believe that FDA should further clarify terms associated with the device CDS intended for healthcare professionals and patient decision support (PDS). For Americans to benefit from the latest advancements in medical devices, there must be enhancements to FDA’s approval process so there is a reduction in time-to-market while still ensuring patient safety and caregiver trust.

FDA made incredible progress in crafting the Software Pre-Certification Pilot Program (in which CHI members participate) based on extensive public input at multiple stages, public workshops, and comments from leading medical SaMD developers. It is essential that FDA continue to support and build on its significant investment in this important effort under and lay the groundwork for a full Software Pre-Certification Program. CHI commits to support Commissioner Hahn moving the Software Pre-Certification Pilot Program forward in order to effectively and responsibly speed time-to-market for trusted developers of SaMD.

Lead the Charge to Bring the Promise of Artificial and Augmented Intelligence-Enabled Technology to American Patients

Artificial/augmented intelligence (AI), powered by streams of data and advanced algorithms, holds incredible potential to improve healthcare, prevent hospitalizations, reduce complications, and increase patient engagement. Yet, applications of AI in healthcare give rise to a variety of potential challenges for U.S. policymakers to consider including quality assurance, adaptiveness, ethics, oversight, notice/consent, bias, and other concerns.

CHI reminded Commissioner Hahn that FDA must take a leading role in standardizing what software capabilities fit the criteria of AI and bring locked AI medical devices to the marketplace responsibly. Currently, healthcare AI systems may inform real-world workflow and evidence, reflect human-centered designs, contain usable principles, and provide for end-user needs to facilitate the “Quadruple Aim.” However, policymakers should begin to address the role of AI in healthcare.

CHI’s AI Task Force developed a set of healthcare AI policy principles that address the range of opportunities and challenges associated with AI in healthcare and propose the appropriate role of government regulations. CHI urges FDA to directly address the role of AI in new standalone guidance providing a scalable, risk-based approach when handling regulatory and enforcement discretion.

Fully Leverage Real-World Data (RWD) and Real-World Evidence (RWE) in FDA Processes and Decision Making

CHI agrees with FDA’s public acknowledgment that RWD and RWE can and should play a key role in FDA’s efforts to monitor post-market safety and adverse events, as well as to make regulatory decisions. CHI members widely use RWD and RWE to support product design, clinical trials, and studies to innovate. We encourage FDA to fully leverage this important data by engaging our members in its processes. FDA should prioritize widespread changes to processes and policies when it comes to using RWD and RWE to make timely informed decisions.

Revisit FDA’s Proposed Approach to Prescription Drug-Use-Related Software (PDURS)

CHI remains concerned with the Center for Drug Evaluation and Research’s (CDER) proposed approach to the Prescription Drug-Use-Related Software (PDURS) in Draft Guidance, which would depart from the Center for Devices and Radiological Health’s (CDRH) work to modernize FDA’s approach to the regulation of SaMD. For example, CDER’s approach to PDURS would take a situation-based approach, as opposed to the CDRH’s risk-based approach to SaMD. Further, CDER’s proposed approach to PDURS would expose software developed by a drug company to significantly longer approval timeframes, placing PDURS at an arbitrary disadvantage to SaMD overseen by CDRH. We recommend that FDA align its approach to PDURS with its widely supported approach developed by CDRH for SaMD.

Continued Leadership in the International Medical Device Regulatory Forum (IMDRF)

CHI supports FDA’s efforts to ensure the safe, secure, and effective exchange and use of de-identified data between devices, products, technologies, and systems. We believe that FDA can and should lead in collaborative efforts addressing medical device interoperability between all stakeholders.

CHI supports FDA’s ongoing efforts to address emerging technology issues within the IMDRF, producing important frameworks for regulatory approaches that utilize a risk-based and scalable approach (such as the IMDRF’s Software as a Medical Device (SaMD): Clinical Evaluation). As our members’ innovative technologies begin to enter regulatory processes, they need FDA’s leadership more than ever in correlating this arena to existing domestic law and regulation. We encourage Commissioner Hahn to continue the FDA’s engagement in IMDRF and for FDA to clarify IMDRF guidance and positions where consistent with U.S. law.

While FDA has no shortage of priorities before it, the willingness of the agency to hear from connected health stakeholders like the CHI membership is encouraging. CHI will meet with Commissioner Hahn to discuss these recommendations later this month.