INSIGHTS
Voice of the Entrepreneur
March 25, 2019

Want to create meaningful change in the US healthcare system? Serve a “tour of duty” in the government

The future of American healthcare is tightly bound to what happens within government. But there’s too little participation by the healthcare innovation community on national policy and regulatory issues. Without a seat at the table, incredibly important decisions are being made everyday with minimal input from entrepreneurs and innovators. As such, it has never been more critical for people traditionally from the private sector to lend their expertise, experiences, and insight to government agencies. There are numerous opportunities to get involved at the federal level, from the US Digital Service to the Presidential Innovation Fellows (we’re proud to have Rock Health’s own Keith Muth serving as a Deputy Director). We interviewed three health tech leaders who have completed a “tour of duty” in the US government—Mina Hsiang, Andy Coravos, and Ryan Panchadsaram. They shared how their time in service has shaped their careers, and why other innovators should consider contributing their talents to the government to have a nationwide impact on healthcare.

Why did you decide to do a “tour of duty” in government service?

AC: In recent years we’ve increasingly become more honest with our phones than with our doctors. From smartwatches that can detect abnormal heart conditions to video games that treat ADHD, digital medicine technologies have huge potential to provide personalized care from the privacy of one’s own home.

On the flipside, personalized medicine also comes with high rates of monitoring and surveillance, a superpower that should not be considered lightly. I hope to spend my career accelerating the ethical adoption of these types of technologies. For my government service, I wanted to serve within a group drafting the policies for software and AI regulation. During my time at the FDA, I worked on Pre-Cert, a program aimed at enabling faster, nimbler software updates for digital health products. Can you imagine if Google could only ship code updates once a year? That’s what many device manufacturers have to deal with today.

Pre-Cert shifts this constraint, which is game-changing for developers: if the Pre-Cert pilot program is successful, “pre-certified” software manufacturers will be able to ship code updates faster and more often while maintaining reasonable assurance of safety and effectiveness.

RP: I wanted to make a difference in healthcare and felt that the startup I was building was only scratching the surface. We were doing meaningful things, but at scale, it likely would only have improved one corner of healthcare. My first tour of duty was as a Presidential Innovation Fellow at the Department of Health and Human Services, where my team was charged with improving access to personal health information. As a technologist, I was able to help bridge the needs and wants of patients with the technical requirements on EHRs.

My former boss Megan Smith often says, “Go where you are rare.” By doing a tour of duty, you get to use your skills in the service of our country. What’s even better is that you get to learn from a passionate group of policymakers who are in government today. Together, you get to shape (and improve!) how our healthcare system functions.

MH: Whether we want to admit it or not, government is at the center of US healthcare. I saw this from every job I had across the sector: Government sets the rules of the game, pays a plurality of the bills, and provides us with services like Medicare, Medicaid, Tricare, or the VA when we need medical care the most. It also directs, regulates, and funds most medical innovations. I wanted to use my skills and experience in the most high-impact way, so it was the obvious choice.

People often ask me, “How much can you actually get done while you’re in government?” For almost every meeting I went to, every plan I worked on, the outcome was different because I was there, in a way I could clearly see. I can draw a straight line from my presence to decisions and tools which affect 100M people.

Photo by Pete Souza

Where in government can innovators and technologists work to have the most impact on our healthcare system?

RP: Find the agency that pulls at your heartstrings. If you want to help our elderly and most vulnerable, look for opportunities at CMS. If your interests are in advancing interoperability, care coordination, and patient access to health records, explore ONC. If you want to directly affect care, look at the VA or DHA. If medical devices and pharmaceuticals are your passion, work for the FDA.

AC: Pick a problem that is vexing society today that needs a coordinated government response, and embed your expertise in that relevant government agency.

For example, our country has strong protections for biospecimens, like blood, urine, and genomic samples—but not for our “digital specimens.” Today, insurers and data brokers can use your everyday digital data to predict your health costs without your consent. We need better regulatory and legal protections for digital specimens, including who gets access to them and when. Our country needs experts (like you!) across multiple agencies (FDA, FCC, FTC and more) to re-haul the system for data rights and governance to better serve both patients and citizens.

MH: Join the government, and you’ll be part of a small cadre who know modern technology, with an incredibly valuable perspective everywhere you go. You’ll get to work on programs which serve hundreds of millions of Americans with one of their most critical needs.

If you can’t join, comment on proposed regulations and requests for information (RFIs). Every policy, from evaluating medical devices for cybersecurity, to rules about patient data access, has a comment period. Agencies need your expertise. Government needs to hear from builders to know what will work and what won’t. Big healthcare associations comment on everything—don’t let their voices dominate.

Build reference implementations. Help move policy from “tell me” to “show me,” from PowerPoints to prototypes. CMS just proposed that patients should be able to get their data from their insurer, but the details are difficult. If you submit a pointer to your GitHub solution, CMS can point to it and say “do it like this.”

What are some challenges you faced during your service?

RP: The challenges came in all shapes and sizes. There were large ones like wrestling with Healthcare.gov. There were medium-sized ones like trying to speed up bureaucratic hiring processes. And then there were small ones like not being able to use the tools you were accustomed to, like Google Docs or GitHub.

Some of these challenges caused people to quit, but the ones who stayed (and persevered) found solutions through a combination of grit and teamwork. Healthcare.gov was turned around. Teams like USDS, 18F, and the Presidential Innovation Fellows have found the right hiring authorities and run rigorous processes to bring talented people into the government in record time. Many of the modern tools we are used to working with in the private sector went through federal security checks (FISMA) and are now easily available.

MH: Challenges are really opportunities, right? Government is different—the rules are different and the way you effect change is different. To help navigate it, we wrote the Digital Services Playbook.

One challenge (opportunity!) is that, for the most part, government technology is either old or procured through a slow and suboptimal process. But it doesn’t have to be that way! Helping programs buy newer, more agile technology is a key priority for making the products work better for the public. At CMS, we revamped the whole way that software and infrastructure were built, bought, and iterated on a major program—moving to the cloud and an API-driven architecture, improving the product’s useability and reliability, cutting time to market dramatically and reducing costs by more than a third. CMS was so happy about the changes that they’ve been moving many other programs in the same direction.

AC: One of the challenges is knowing when the government has statutory authority to regulate. All new industries have legal gray area and it takes time and work to figure out the scope of oversight and responsibility. Although the best approach may be to change existing regulations, doing so could take too long given the speed of change in the industry.

If regulatory oversight isn’t the optimal action, the FDA considers other approaches. For instance, last month the FDA’s cybersecurity team launched the #WeHeartHackers project, a collaborative movement between the medical device and security researcher communities. Along with the FDA, medical device manufacturers like Abbott and Medtronic have voiced their support to work collaboratively with security researchers at DEF CON’s Biohacking Village this summer. It’s rare for a government agency to publicly participate in DEF CON, and this forward-thinking collaboration has already led to changes that improve patient outcomes.

https://twitter.com/SGottliebFDA/status/1090280147125764097

What are you doing now? How did your time in government shape your outlook?

MH: Shortly after he left the White House, but when I was still in government, I got a call from Todd Park. “My brother Ed and I are thinking about starting another company, don’t start anything new without calling me first!” They pulled together a bunch of us who have worked in healthcare for a long time to start Devoted Health so we could address the deep problems we had seen that prevent people from getting the right care. We’re a full-stack Medicare Advantage healthcare company singularly focused on taking care of all older Americans like they’re our own family—to smooth out the disjointed experience of healthcare so seniors get the right care in the right place at the right time.

Because I worked in government, I have a different view of the national landscape and who the players are, how policy is likely to change, and where we need to fix things. I also participate more in the policy process than I used to, and I think everyone should.

RP: Right now I work at Kleiner Perkins where I focus on venture-stage companies and serve as an advisor to Chair John Doerr. Together we invest in bold founders and disruptive technologies.
Once you serve in government, you appreciate how important it is. You see how it impacts and influences your life. For example, if you are an aspiring healthcare entrepreneur, you realize how important something like the Affordable Care Act is, because you can take the leap to start a company and not have to worry about your health insurance. Because of offices like CMS and ONC, you can build a company that uses electronic health data and has a reimbursement pathway. Because of the FDA, you can appreciate that there’s a regulatory piece in place to ensure that what you create is safe for patients to use.

We can’t take the government we have for granted. Each of us has to participate and serve.

AC: I co-founded Elektra Labs, a healthcare-security company advancing safe and effective digital medicine. Today, we are focused on supporting pharma and biotech companies who are deploying remote biometric monitoring in their decentralized clinical trials. I’m also serving as an advisor for DEF CON’s Biohacking Village.

I’ve realized interacting with government officials doesn’t have to be intimidating. As technological advancement forces our government to modernize and become more adaptive to better serve citizens, many regulators are looking to interact with industry and build collaborative solutions that create incentives for more self-regulation rather than legal consequences.

Interested? Craft your own tour of duty

Agencies across the government that impact healthcare are looking for all types of roles, including software engineers, data scientists, machine learning experts, UI/UX designers, and product managers. There are many possible avenues to contribute. Here are a handful of examples:

  • President Innovation Fellows (PIFs) are entrepreneurs-in-residence who are paired with top civil-servants and serve a one to two year stint in federal agencies, including the Department of Veterans Affairs, National Institutes of Health (NIH), FDA, HHS, and more. In February, 17 new PIFs were announced. PIF is currently recruiting the summer cohort of Fellows through April 22. Interested candidates may apply at apply.pif.gov.
  • The United States Digital Service (USDS) is a group of elite technology units housed at the White House and several other agencies, including HHS. They provide consultation and develop human-centered solutions to the government’s most pressing technical challenges.
  • 18F is a digital services agency that collaborates with other agencies to fix technical problems, build products, and improve how government serves the public through technology.
  • NIH houses the “All of Us” program, formerly the Precision Medicine Initiative (PMI) Cohort Program, which seeks to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants.
  • Additionally, agencies have worked with universities to develop fellowships, like the FDA’s partnership with the Harvard-MIT Center for Regulatory Science to create a Post-Doc Fellowship in AI and Machine Learning.

The Technology Transformation Services (TTS) jobs newsletter highlights open roles across groups like 18F, PIF, the U.S. Centers of Excellence, Login.gov, Data.gov and Code.gov, though this newsletter doesn’t track many of the agency-specific roles like the EIR role that Andy served in the FDA’s Digital Health Unit.

To make it easier to craft your “tour of duty,” we made a tracker of GovTech roles. (If you are a government employee and your team is actively recruiting, submit your job description and we’ll add it to the tracker). Reach out to Andy, Mina, and Ryan if you have questions as you contemplate your decision to serve and make a meaningful contribution to US healthcare.