HHS Startup Day Boston
At HHS Startup Day Boston, hundreds of startups and industry leaders convened to demystify the government and collaborate on defining the future of health.
PULSE@MassChallenge meets with hundreds of digital health startups every year. As a result the PULSE team is well aware of the common challenges the startup community faces — long sales cycles, regulatory complexity, and fragmented payment models to name a few.
When given the opportunity to be the first HHS Startup Day outside of Washington DC, the Massachusetts planning committee made up of the Massachusetts eHealth Institute (part of Massachusetts Technology Collaborative — Massachusetts’ innovation economy agency), City of Boston, Massachusetts Competitive Partnership, Harvard Pilgrim Health Care, and PULSE@MassChallenge understood the importance of the event to address these challenges.
HHS Startup Day brings together federal and local health leaders to demystify working with the government, share top strategic priorities, deliver unparalleled ease and access to key decision makers, and foster a more collaborative public-private ecosystem.
It comes as no surprise that Boston’s HHS Startup Day sold out days before the event. Massachusetts prides itself as a healthcare and life sciences state. Its largest employer is a health system and the life sciences sector is one of the top economic drivers for the state. The audience (approximately 53% startups) stayed for the entire day in a packed room to learn from and collaborate with the nation’s digital health leaders.
As Bruce Greenstein, Chief Technology Officer of the United States Department of Health and Human Services shared in an interview with MedTech Boston “this is a city that has given the American healthcare economy so much of what we’re enjoying today.”
When he spoke to the audience, the CTO called on the audience of entrepreneurs and leaders to step up and solve the next massive challenges. “What we spend on kidney dialysis is larger than the budgets of NIH, Department of Commerce, or NASA.” Greenstein shared as he lamented the lack of positive change and clinical innovation in that area for over 60 years. Initiatives like the XPrize Competition to design artificial kidneys could be that change.
Lack of data can be a major hurdle in developing innovative solutions, which is why I am focused on liberating data throughout HHS so that startups can effectively tackle major health challenges.
— Bruce Greenstein, CTO HHS
His theme of opening data and creating a data sharing culture received applause at the event, a theme he also shared at the Connected Health Conference in Boston, Startup Health Festival in San Francisco, and HHS Startup Day in Washington DC.
Greenstein also appealed to the audience to get more active and help HHS make better policy decisions. “People don’t know how to access HHS, but we’re working to change that and make the agency more open,” he shared.
Ray Hurd, Regional Administrator for the Centers for Medicare & Medicaid Services (CMS) spoke of extended life expectancies and how the model of care “has to focus on people in their 80s, 90s, and 100s.” Generally, when working with CMS, they’re looking to answer the following question “is it meaningful to the patient?”
For Medicare beneficiaries, their top three most important issues are:
- Independence
- Quality of Life
- Functional Status
Understanding that innovation may be the key to providing the level of quality CMS is aiming for, he suggested that the entrepreneurs in the room learn more about the Center for Medicare and Medicaid Innovation (CMMI) and the CMS Innovation Center. The CMS Innovation Center develops and tests new payment models to drive the future of payment and service models.
One of their most exciting initiatives Blue Button 2.0 is putting data in the hands of patients to reduce patient burden and streamline information to improve health outcomes with a more centralized and patient-centered approach.
He also described the joint efforts between CMS and the Food and Drug Administration (FDA) to reduce the time to market for solutions with the parallel review process. For medical devices, getting reimbursed by a payor was a separate approval process that followed FDA approval. Hurd emphasized this process was changing with parallel review.
For Esther Bleicher, Senior Policy Advisor to the FDA she spoke about how “guidance is not binary.” They understand that as regulators they have to protect the American people, but also enable innovation and the flexibility for unknown changes. Ultimately, the FDA is responsible for the safety, effectiveness, quality, and security of drugs, food, medical devices, and many other items. While they regulate a lot and provide many guidelines, it’s a priority of the FDA to clarify the process and enable more innovative solutions to thrive.
5 key components of the FDA:
- Premarket review
- Regulations
- Guidance
- Outreach and Engagement
- Enforcement
“We recognize that the way medical devices have been regulated over the last 50 years isn’t going to work for the next 50, particularly for digital health.”
— Esther Bleicher, Senior Policy Advisor to the FDA
The key for anyone looking to get approval by the FDA is to reach out. Bleicher highly encouraged digital health entrepreneurs to reach out to the FDA through their website and email digitalhealth@fda.hhs.gov.
For the National Institutes of Health (NIH), Jessica Mazerik, Special Assistant, Immediate Office of the Director expressed NIH’s passion for “science in pursuit of fundamental knowledge about the nature and behavior of living systems… and the application of that knowledge to extend healthy life and reduce illness and disability.”
Mazerik shared NIH’s excitement to fund the people in the room to pursue research through programs like the small business innovative research grants (SBIR / STTR), challenges and prize competitions, and grants like their data science initiative.
Teresa Zayas-Cabán, Chief Scientist and Stephen Konya, Senior Innovation Strategist for the Office of the National Coordinator for Health Information Technology (ONC) spoke next about their priorities to make health information more accessible, decrease documentation burden, and support EHR usability under the 21st Century Cures Act and MACRA.
As Chief Scientist, Zayas-Cabán spoke of her work on the Precision Medicine Initiative (PMI), patient-centered outcomes research (PCOR) projects, and how ONC coordinates relevant scientific efforts across other HHS and Federal agencies.
The Precision Medicine Initiative has the goal of enabling a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care. ONC helped create APIs that demonstrate the feasibility of the initiative.
Konya, spoke to ONC’s role as a “one stop shop” for HHS Health IT resources with implementation environments like SITE, challenges like the Provider User Experience Challenge (won by PULSE@MassChallenge 2017 startup Herald Health), and the Mobile Apps Interactive Tool built in partnership with HHS, Federal Trade Commission, Office for Civil Rights (OCR), and FDA.
After the federal leaders spoke, the audience heard from Laurance Stuntz, the Director of the Massachusetts eHealth Institute (MeHI) about the Massachusetts Digital Health Initiative. He encouraged entrepreneurs to take advantage of the amazing opportunities in the state.
Stuntz also serves on the Massachusetts Digital Health Council where they are currently focusing on the following three areas:
- Data
- Piloting and Product Validation
- Digital Health Ecosystem Building
There are over 300 digital health focused companies already in the Massachusetts Digital Health cluster and the agency he oversees is the official front door to the digital health initiative in Massachusetts. He told the audience if they wished to learn more about digital health in Massachusetts, they should visit massdigitalhealth.org
As a Champion of PULSE@MassChallenge, MeHI partnered with the Commonwealth of Massachusetts’ Executive Office of Elder Affairs to host a challenge in this year’s program as part of their efforts to support the startup ecosystem while also driving improved health outcomes for the people of the Commonwealth.
How many of you are getting older?
— Alice Bonner, Secretary, Massachusetts Executive Office of Elder Affairs
Secretary Bonner spoke of the important role technology is playing and will play for the aging population of Massachusetts. People should be able to “age with a purpose” she said. She called on the entrepreneurs in the room to help make Massachusetts the “Silicon Valley” of aging and technology.
Following the speeches, the audience broke for lunch and later breakouts where they could spend small group time with the speakers from the morning and representatives of local institutions on a variety of topics.
The day was capped off by five incredible pitches from some of Boston’s most impressive startup companies:
- Act.MD — A company that simplifies and coordinates complex care. They were a PULSE@MassChallenge 2017 company.
- DynamiCare Health — A company addressing the opioid epidemic through evidence based interventions. They are a PULSE@MassChallenge 2018 company.
- Neuroelectrics — A digital brain health company that can monitor and stimulate the brain to help treat neurological conditions. They were a PULSE@MassChallenge 2017 company.
- PatientPing — A company that connects healthcare providers across the country with meaningful patient data.
- Pillo Health — A company with a companion robot for your health. They are a PULSE@MassChallenge 2018 company.
All startups walked away with offers to spend time with amazing panel of judges.
While many of the attendees held PhD’s, MDs, MBAs, and other higher level degrees and certifications, most shared a certain level of shock over how much of the material covered during the day was either new to them, more detailed, or more clear than it had ever appeared before. As someone without any such degrees, this writer wishes to emphasize the importance of the HHS Startup Day tour and its power to make clear the opaque.
Check out the slides from HHS Startup Day Boston here. You can also read about HHS Startup Day Boston in the Boston Business Journal, MedCity News, MedTech Boston, and Mobihealth News. If you want to learn more about the Office of the CTO and the Idea Lab, visit: https://www.hhs.gov/idealab/
The next stop on the U.S. Department of Health and Human Service’s nationwide tour is Chicago on May 24th.
