One of the most important elements of an optimized healthcare system is aligning treatment goals among the various stakeholders. While alignment between physicians, payers, and patients is not always easy to achieve, recent advancements in technology have provided patients with an unparalleled ability to actively participate in treatment decisions and maintain a share of control relative to managing their desired health outcomes. Today’s patients are more sophisticated than ever due to the availability of information surrounding disease states and treatment options that empower them to make more informed decisions about their own care. The result has been an increased interest in the adoption of patient-centric healthcare models and treatment regimens: those that highly prioritize the issues most pressing to the patient and address barriers related to the costs, quality, and access to care.
Quoting Dr. Gottlieb, the former Commissioner of the Food and Drug Administration, “Digital health tools have vast potential to improve our ability to accurately diagnose and treat diseases. And to enhance the delivery of healthcare for the individual, making medical care truly patient centric -- empowering the individual.” Digital health is a broad descriptor that ranges from the technologies which receive and transmit data to the medical devices themselves. In an effort to improve access and reduce the cost of bringing these innovations to market, the FDA has initiated new directives and policies utilizing RWD to generate RWE.
The FDA has issued guidance documents and industry publications to assist in the understanding of and expectations from pre- to post-market decisions in the development and implementation of digital health products. One of the more ambitious pieces, The Digital Health Innovation Action Plan, lays out the agency’s vision for fostering digital health innovation while continuing to protect and promote public health. This plan confirms that the FDA is focused on oversight of software applications and devices that present a high risk to patient safety and also maintains an interest in developing alternative regulatory approaches to low-risk products. One such alternative approach is seen with the Software Pre-Certification Pilot Program which will shift agency focus to approving trusted software developers as opposed to reviewing individual software applications. This strategy will allow quicker commercialization of digital health technologies while conserving limited agency resources. Over time, these approaches may reduce healthcare costs and increase access to new technology that is designed for patient-centric precision medicine.
The FDA’s recent initiatives surrounding RWE create both opportunities to spark innovation and new responsibilities to design studies and generate evidence, with the onus on the RWE research community to use reliable and relevant RWD. As new technologies that capture RWD are developed, new methodologies will be necessary to validate the insights derived from their use, while never losing sight of the patient as the primary stakeholder.