The U.S. Food and Drug Administration has launched a new initiative, the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO. It's designed as a voluntary effort to improve the health of chronic disease patients by promoting safe access to specific digital health devices.
WHY IT MATTERS
The new pilot, developed by the FDA's Center for Devices and Radiological Health (CDRH), seeks to explore what agency officials are a calling a "risk-based enforcement approach" that supports digital health tools that could improve patient outcomes for cardio-kidney-metabolic, musculoskeletal and behavioral health conditions.
"Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace," said Center for Devices and Radiological Health Director Dr. Michelle Tarver.
"The TEMPO pilot will allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives," she said.
The project is being embarked upon in collaboration with the CMS Innovation Center to help advance its Advancing Chronic Care with Effective, Scalable Solutions, or ACCESS, model, which was developed to boost access to integrated, technology-enabled healthcare.
As part of the TEMPO pilot, certain digital health device makers will offer tools designed for specific conditions covered by the CMMI ACCESS model.
These could include low-acuity cardiometabolic conditions such as prediabetes, the agency notes, or more complex conditions such as heart failure; also, musculoskeletal issues such as back strain or behavioral health conditions such as depression.
Device developers will collect and report real-world data on how well their tools have helped improve care delivery for patients. The aim is for FDA and CMS to better understand how digital health tech performs – and how the agencies can better support chronic disease management across the U.S.
The FDA notes that "participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device's performance."
Those developers taking part in the TEMPO pilot will collaborate with the FDA to find the circumstances where enforcement discretion may be appropriate for a given manufacturer's device.
THE LARGER TREND
The TEMPO pilot, which the FDA says is "designed to align with the rapid and iterative nature of digital health development," is a new component of the agency's Home as a Health Care Hub project.
Expanding access to digital tools that can be used safely and effectively in the home is a key strategy to improve the management and treatment of chronic disease.
The pilot also draws on CDRH's experience with the Total Product Life Cycle Advisory Program, which has shown how early collaboration and proactive input can streamline device development.
The goal is to select as many as 10 manufacturers in each of four specific clinical use areas. The FDA says it's seeking statements of interest for participation in the TEMPO pilot starting in January.
ON THE RECORD
"We are piloting an approach to encourage the use of digital technologies that meet people where they are," said FDA Commissioner Dr. Marty Makary in a statement. "This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease."
"CMS is pleased to partner with the FDA on the TEMPO pilot as we work to modernize care for people with chronic disease," added CMS Administrator Dr. Mehmet Oz. "Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care."
Mike Miliard is executive editor of Healthcare IT News
Email the writer: mmiliard@himss.org
Healthcare IT News is a HIMSS publication.
