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News - FDA Unveils TEMPO Pilot to Expand Access to Digital Health Tools for Chronic Disease Care

December 2025 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group


The FDA has announced the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary initiative aimed at improving access to certain digital health technologies while maintaining patient safety.


Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will test a risk-based enforcement approach for digital health devices designed to enhance patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”


The program will operate in collaboration with the Centers for Medicare and Medicaid Services (CMS) Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Under TEMPO, participating manufacturers will provide devices intended for care covered by the ACCESS model while collecting and reporting real-world performance data. This effort aims to help both agencies understand how these technologies perform in everyday settings and how they can support chronic disease management.


“CMS is pleased to partner with the FDA on the TEMPO pilot as we work to modernize care for people with chronic disease,” said CMS Administrator Mehmet Oz, M.D. “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”


Manufacturers in the pilot may request FDA enforcement discretion for certain requirements, such as premarket authorization, while sharing real-world evidence of device performance. The approach is intended to align with the rapid development cycle of digital health tools and broaden patient access to innovative solutions. Eligible devices may address conditions ranging from prediabetes and heart failure to musculoskeletal issues like back strain and behavioral health concerns such as depression.


“Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace,” said CDRH Director Michelle Tarver, M.D., Ph.D. “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.”


TEMPO is part of the FDA’s Home as a Health Care Hub initiative, which seeks to bring care into daily environments and reduce the burden of chronic disease. Drawing on lessons from the Total Product Life Cycle Advisory Program, the pilot emphasizes early engagement, iterative development, and real-world data collection.


The FDA will begin accepting statements of interest in January 2026 and plans to select up to 10 manufacturers in each of four clinical areas. The initiative represents a significant step toward expanding technology-enabled care and improving health outcomes nationwide.


For more on digital health innovation in device development, attend the “Digital Tools and Connectivity for a Maximised User Experience” stream at the PFS Europe Conference in January.

 



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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