Skip to main content

FDA Digital Health Center of Excellence

Last month, the U.S. Food and Drug Administration announced the formation of its Digital Health Center of Excellence (DHCoE), a combination of virtual and dedicated resources housed within the Centers for Devices and Radiological Health designed to support developers of digital health products and devices. 

The FDA defines digital health as

"mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine" that have the "potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual."

Recognizing that technology is advancing rapidly, and that innovation is promoting interconnectivity between health devices, health care providers, and information systems, the FDA saw a need to reform its own workflows in ways that empower the developers of digital health products with the information needed to balance the risks and rewards of digital health.

The DHCoE is not responsible for reviewing and providing marketing approval for digital health products -- that responsibility remains with the appropriate regulatory group. It does however, aim to align the FDA's goals with regard to digital health and to provide knowledge and expert advice to product developers.

The DHCoE will be focusing on a range of issues initially. By concentrating its efforts on such as the role of artificial intelligence, wearable devices, virtual or augmented reality, digital pathology and others, the DHCoE aims to harmonize the FDA's own efforts and provide enhanced clarity to stakeholders.

By engaging with stakeholders, the DHCoE expects to solicit input ensuring that the voices of developers, patients and others are reflected in its work. Further, the DHCoE will build partnerships with and between stakeholders in order to create a broad community that can encourage interaction and learning. Finally, the DHCoE expects to coordinate with other regulators in order to identify the need for and to facilitate harmonization between regulatory needs and requirements.

The FDA will hold two listening sessions allowing stakeholders and other interested parties to provide input to the development and direction of the DHCoE. The first listening session invited a panel of representatives from the medical device, consumer technology, investor, provider and patient communities to share thoughts and ideas on the goals and outcomes of the DHCoE. 

Panelists applauded the efforts to increase transparency into its regulatory processes and its efforts to coordinate and harmonize efforts across the industry. Stakeholders urged DHCoE to continue forward on its path by developing education aimed at companies that have not historically worked with the FDA and to educate providers and patients alike on the devices that are being used and how they are being used in their own self-management of their health care. 

Acknowledging its limitations, DHCoE recognizes that it must be strategic in how it collaborates and interacts with technology developers. By striving for the best bang for their buck, they want to make sure that it is coordinating with the correct stakeholders. There was acknowledgement that some technology is not regulated by the FDA -- wellness apps for instance, leaving a gap between consumer grade and health grade technology.

Another gap that the group discussed was reimbursement. The FDA recognizes that it does not regulate payer coverage or payment. This potentially leaves a major gap that could negatively impact developers ability to market digital health solutions. If payers are not adequately involved in the policy making process, or if discrepant regulatory requirements are not harmonized, digital health may find it difficult to develop broad payer acceptance. Stakeholders also encouraged a parallel-review like process that would help to remove this barrier.

A second listening session will be held on November 12th to collect additional thoughts and ideas from stakeholders.

Labels:

Comments

Post a Comment

Popular posts from this blog

The Problem of Limited-Supply Agreements for Medicare Price Negotiation

A recent JAMA Viewpoint article discusses how limited-supply agreements between brand name and generic drug makers could impact Medicare price negotiation under the Inflation Reduction Act (IRA). These agreements allow brand manufacturers to maintain some market exclusivity by limiting the supply of generic competitors. The article suggests these deals may increase as the Centers for Medicare and Medicaid Services (CMS) implements the IRA's price negotiation provisions. From a business perspective, it's understandable why brand manufacturers might find limited-supply agreements preferable to having their drugs subject to Medicare negotiation. Maintaining even partial exclusivity is likely better for revenue than triggering government-dictated price reductions. However, policymakers and patients are increasingly concerned that these deals keep prices high despite generic availability. The use of limited supply agreements could also produce unintended consequences.  Balancing som...
Post a Comment
Read more

FDA Green Light Inches Genetic Screening Forward

The FDA recently granted authorization for the first multi-gene test for assessing hereditary cancer risk, marking a significant advancement in genetic screening capabilities. Developed by Invitae Corporation, the Invitae Common Hereditary Cancers Panel analyzes variants in 47 genes associated with increased cancer risk. Using next-generation sequencing on DNA from blood samples, the test looks at BRCA1 and BRCA2 variants linked to breast and ovarian cancer, as well as other cancer-related genes.  (image source: Adobe Stock Images) The FDA’s approval provides a regulatory framework giving labs a clearer roadmap for developing similar multi-gene panels. With an authorized model in place, labs can proceed more confidently in navigating FDA submissions. Specifically, the de novo classification created for Invitae’s test allows future lab-developed panels to gain regulatory clearance through the expedited 510(k) pathway by demonstrating substantial equivalence. This streamlined validat...
Post a Comment
Read more

The Future of Liquid Biopsies: Endless Possibilities for Cancer Testing

Liquid biopsies are poised to disrupt cancer testing as we know it. These novel blood tests analyze circulating tumor DNA (ctDNA) and other molecules released by cancer cells, providing a non-invasive option for detection, diagnosis, and monitoring. The promise of liquid biopsies has generated tremendous excitement, along with over $1 billion in investments and acquisitions in recent years. But how close are we to realizing their full potential?  A recent review article sounds a note of caution amidst the hype. While liquid biopsies show ability to detect cancer, evidence that they improve patient outcomes is still lacking. Randomized trials with survival endpoints are needed to prove clinical utility. However, this provides the perfect opportunity for innovative diagnostics companies. Rather than dampening enthusiasm, these evidence gaps highlight major growth possibilities if companies can demonstrate real-world value.   We envision liquid biopsies transforming oncology...
Post a Comment
Read more