TEMPO and FDA enforcement discretion

After three decades working to deliver easy, fast and cost-effective patient experiences through technology, Ryan Howells is more optimistic about the future than he’s ever been before.

At a time when healthcare has been at the center of polarizing and partisan politics, Ryan is focused on an area foundational to digital health that he says draws consensus across party lines: data exchange and interoperability. Freely moving data can unlock innovation in technology, payment models, and regulation to make healthcare work better for everyone, and Ryan is extremely encouraged by the openness to ideas and volume of activity he’s seeing from the second Trump Administration in these areas.

As Principal at Leavitt Partners since 2015, Ryan collaborates with the private sector, the White House, Congress, HHS, and the VHA to improve health care nationwide. For the past ten years, he has also led the CARIN Alliance, a bi-partisan, multi-sector alliance uniting industry leaders to advance the adoption of consumer-directed exchange across the U.S.

In January 2023, Ryan joined Keith Figlioli on the podcast to discuss the myriad of new possibilities emerging in healthcare as a result of better access to data. In this episode, he recounts the progress and obstacles since that conversation, but more importantly, helps unpack the flurry of new activity.

Topics Ryan and Keith covered include:

• ACCESS & TEMPO. These are the latest examples of two new government programs that Ryan believes will remove barriers to innovation. ACCESS is a CMS initiative that now makes it possible for technology companies to bill Medicare directly for digital health services – and get paid only when patients achieve specific, measurable clinical outcomes. Ryan explains how ACCESS is a breakthrough for transparency and has the potential to change contracting for digital health vendors as health system may now ask to share risk. TEMPO is a program from the FDA that complements ACCESS by allowing participating companies to bypass traditional device clearance processes through “enforcement discretion,” provided they share real time data with the FDA. Ryan explains how this oversight lowers cost and complexity for startups and accelerates the path to market for new digital health solutions.
• Removing administrative roadblocks. In early 2025, Ryan’s team at Leavitt Partners published a paper titled, “Kill the Clipboard” that offered recommendations to cut administrative costs, lower the burden on consumers and providers, and modernize the health care data exchange ecosystem. Ryan discussed recommendations like the need for stronger enforcement of information blocking rules and suggestions for the government to change its certification program to focus on APIs, versus functionality of EHRs. He explained how these things would allow health systems to control their own data, build cloud-based workflows, and integrate with payers and innovative companies more easily.
• Linchpins for data liquidity. Ryan believes that achieving true data liquidity in healthcare requires three foundational elements: a cloud-based data store, an API endpoint, and robust digital identity credentials. With these in place, he says organizations can exchange data securely and efficiently, supporting everything from public health to quality measurement and pharmacy exchange. He says these are the linchpins to finally achieve the data liquidity needed for innovation, interoperability, and improved patient outcomes.

To hear Ryan and Keith discuss these topics and more, listen to this episode of Healthcare is Hard: A Podcast for