Quick Summary
The FDA announced the TEMPO pilot, tied to patient outcomes for certain digital health devices. This is important because it suggests more structured pathways where adoption and access can improve, as long as safety and real-world performance are measurable. It is also a signal that digital health will increasingly be evaluated like healthcare infrastructure, not consumer apps.
What the FDA announced
The FDA posted an update describing the “Technology-Enabled Meaningful Patient Outcomes (TEMPO)” pilot for digital health devices, positioned alongside broader efforts to promote access while safeguarding safety. FDA Digital Health Center of Excellence update (TEMPO pilot).
The deeper signal: outcomes as the primary currency
A lot of digital health has struggled because it could not consistently show outcomes in deployment. Hospitals and payers do not want another dashboard. They want measurable impact.
- Clinical outcome clarity: what improves, and for which patient cohorts?
- Real-world monitoring: how do you detect drift, failures, and unintended consequences?
- Evidence packaging: can an organization evaluate your tool without a multi-month project?
Why this matters for founders and product teams
If you build in digital health, a pilot like this changes how you should think about product strategy:
- Design for measurement from day one (baseline, change, and persistence).
- Make clinical workflow integration a first-class requirement.
- Build safety processes like monitoring, escalation, and rollback into the product.
- Treat documentation and claims logic as part of the system, not an afterthought.
Where Aether fits
Aether is building the foundation layer that outcomes depend on: longitudinal records that are clean, structured, and shareable. If a patient’s history is fragmented, outcome measurement is distorted. If history is structured over time, clinicians can see changes, and systems can measure impact.
- Structured timelines improve continuity and reduce repeated testing
- Context improves clinical interpretation and follow-up reliability
- Provenance supports trust and governance
Sources and further reading
- FDA Digital Health Center of Excellence: TEMPO pilot announcement
- FDA overview: AI and Software as a Medical Device (SaMD)
- FDA draft guidance: AI-enabled device software functions lifecycle management
Information only. Not medical advice.
Next steps
- If you are building a digital health device, define measurable outcomes early.
- Plan for real-world monitoring, not just validation studies.
- Build trust through provenance and longitudinal context.