When the federal government promises to make something simple, people listen. This statement captures the spirit of Startup Days featuring HHS, which aim to simplify and streamline the engagement process between startup companies and the Department of Health and Human Services.
Startup Days are designed to connect with local entrepreneurs and developers and educate them on resources available across HHS agencies. On Nov. 8, HHS spent the day in Cleveland, OH at the HIMSS Innovation and Conference Center during this event organized by HIMSS and BioEnterprise. After previous Startup Days in Boston, Chicago and Atlanta, the Cleveland visit provided a platform to learn from a panel of government agency leaders and obtain feedback on how startups can interact with these stakeholders effectively.
Three Pillars of Innovation
Ed Simcox, Chief Technology Officer of HHS, kicked off the day with an overview of the HHS relationship with innovation and his mission to make HHS a “less opaque, byzantine place to do business with.”
Outlining three pillars of innovation, Simcox highlighted ongoing efforts within the HHS Office of the CTO to foster novel solutions to healthcare:
- Data: HHS has historically owned a lot of data that wasn’t readily shared or accessible. Now, HHS is working to better share this data externally and across agencies. These inter-agency sharing efforts culminated in an Opioid Code-a-thon in 2017 to leverage previously disparate data to solve the epidemic.
- Talent: HHS recognizes that talent outside of its departments will be key to disrupting the current healthcare environment and offers programs to educate and engage with these external innovators. Their IDEA Lab offers courses and boot camps to expand one’s data language and their Entrepreneurs-in-Residence (EIR) programs offers an accelerated path for non-government individuals to fill positions to inform HHS work.
- Partnerships: As highlighted in the first two pillars, collaboration is key to driving innovation. The Startup Days event is one example of public-private partnerships to spread HHS’s message. KidneyX is another example, in partnership with the American Society of Nephrology, that seeks innovation in a health field that has seen very little change in prevention, diagnostics and treatment. This accelerator plans to engage the community by offering resources and engaging developers in prize competitions.
Innovation Driven by Social Determinants of Health
In a meeting of innovative leaders, Simcox next sat down for a fireside chat with Steve Wretling, HIMSS Chief Technology & Information Officer, to discuss the role social determinants of health (SDOH) play in HHS’ efforts to achieve value-based care. They agreed it all boils down to the data and that value-based care is about shifting from quantity to quality. While fee-for-service reimbursement is predicated on structured data, value-based care is a more nebulous environment of unstructured data, clinical notes and interpretation of how each input affects care. SDOH will play a role in understanding what affects health and outcomes, they said.
Simcox and Wretling also discussed the nascent work around SDOH. While it is still in the beginning phases of understanding outcomes, there are plenty of anecdotes on its importance to improving care. HHS is continuing to learn from these early efforts to better understand how they can support novel solutions that consider social improvements to health. These include efforts by the Centers for Medicare & Medicaid Services (CMS) to rethink reimbursement and the Office of the National Coordinator for Health Information Technology (ONC)’s mission to advance interoperability and liberate data needed to create a connected health ecosystem.
Government Agencies: A Conduit to Innovation
Other government agency panelists joined Simcox in a session led by Tom Leary, HIMSS Vice President of Government Relations. They educated the audience on specific ways to engage with each of their organizations. Each panelist started by providing a brief overview of how each of their agencies work with startups:
- Paul Howard, Senior Advisor to the Commissioner, Food and Drug Administration (FDA) highlighted how FDA regulations are technology-specific and tailored to each disease state. By working with the FDA, developers can engage on the regulations related to their product, obtain guidance on innovative clinical trial design and understand if their product qualifies as addressing rare or orphan disease, which provides additional benefits.
- Stephen Konya, Senior Innovation Strategist, Office of the National Coordinator for Health IT (ONC) shared how the ONC focuses on data capture and transmission. As outlined in 21st Century Cures Act, the ONC has been pushing for open APIs to unlock platforms and integration. They are also publishing information blocking guidance that defines the term and outlines penalties for infractions in an effort to discourage vendors from participating in activities that impede access to health information.
- Amy Freedman, International Trade Specialist, Department of Commerce provided guidance for the business side of startups. Her agency helps startups understand market trends and regulatory process abroad to design an implementation strategy at a broader, global scale.
- Jessica Mazerik, Special Assistant to the Principal Deputy Director, National Institute of Health (NIH) shared that NIH has a $1 billion budget set aside for small business and technology development funding programs and includes 27 centers and institutes available to provide disease-specific resources.
Attendees then participated in an open Q&A with panelists addressing topics ranging from reimbursement for novel care delivery models, interoperability and data blocking, to outcome measures, global health partnerships and the non-technical aspects of data sharing. These conversations continued during a networking lunch, where attendees had the opportunity to engage individually with each panelist for further guidance.
Flexing the Startup Pitch Muscle in Cleveland
The payoff moments for entrepreneurs came in an afternoon pitch session. Local startups discussed their SDOH innovations and obtained valuable feedback from the panelists regarding approaches to engaging with HHS to identify new opportunities.
Community-based innovations were also highlighted in presentations from BioEnterprise/Accenture’s Healthcare Data Lab, MetroHealth’s Global Health Metrics platform and JumpStart’s Core City Incubator.
The day in Cleveland wrapped up on a local note, with an emphasis on the value of Cleveland in the U.S. health innovation community, as the “medical capital” city continues its mission to attract the brightest minds in health IT.