In 2017, the FDA launched its Digital Health Innovation Action Plan, detailing its plans to review and update regulation of software. Among the digital health programs is the Pre-Certification Program, also known as Pre-Cert, wherein FDA is working with innovators to develop a new approach to regulatory oversight for software-based medical technologies. Nearly two years into the pilot program, we wanted to get a status update and hear what’s in store this year and beyond. 

Rock Health Managing Director and CEO Bill Evans caught up with Bakul Patel, the FDA’s Director for Digital Health, and Jared Seehafer, cofounder and CEO of Rock Health portfolio company Enzyme, to discuss the FDA’s new look, the proposed framework for regulating AI and machine learning, and how startups should navigate—and participate in—the evolving regulatory process.

The Current State of Digital Health Regulation

Hear from insiders across healthcare and technology and get the scoop on the latest trends in digital health. 

Rock Health exists to fund and support entrepreneurs working at the intersection of healthcare and technology. Join us and build something useful. Visit us at www.rockhealth.com.

Health & Fitness

Recorded at Rock Health Summit 2020 

Countless players have tried their hand at mastering the holy grail of healthcare: better care at lower costs. Big retail and telecom are next in the ring, and they just might have what it takes. These behemoths excel where traditional healthcare and tech companies have faltered—they unify digital and physical assets to get consumers what they need, when they need it, where they are. Whether it’s in-store foot traffic or in-home service teams, retailers have unparalleled access to consumers through existing relationships outside the healthcare system. But will that be enough? Hear from the strategics behind retail and telecom’s bold, potentially transformative moves into healthcare.

Moderator: 
Erin Brodwin, Health Tech Reporter, STAT

Panelists: 
- Sujata Gosalia, EVP and Chief Strategy Officer, Cox Communications 
- Marcus Osborne, SVP, Walmart Health
- Daniel Grossman, MD, Chief Medical Officer, Best Buy

Do Big Retail & Telecom Hold the Key to Healthcare’s New Front Door?

Evidation Health and Omada Health, two of Rock Health’s portfolio companies, are trailblazers in their respective domains in digital health. Both have heritage as evidence-driven and evidence-generation platforms, and together they’re designing the gold standard of decentralized clinical trials. As COVID-19 pushes the industry to gather novel clinical data digitally, Evidation Executive Director of Digital Health Outcomes Dr. Jessie Juusola and Omada Senior Director of Clinical Research & Policy Dr. Cynthia Castro Sweet sat down with Rock Health CEO & Managing Director Bill Evans to share how they’re bringing value to the future of clinical trials by meeting people where they are.

The Inevitable Shift to Decentralized Clinical Trials

Digital health funding had a wild ride through the first half of 2020—first hitting a record $3.1B in Q1, then hitting the brakes in April as COVID-19 spread rapidly around the globe. Despite this downswing, investors came roaring back in May as several regulatory and reimbursement barriers to digital health adoption were brushed aside in a rush to keep healthcare systems operational in the midst of the pandemic.

Rock Health Managing Director & CEO Bill Evans shares some surprising insights about fundraising in the midst of a pandemic and recession in his conversation with Kaiser Permanente Ventures Director Liz Rockett, Bessemer Venture Partners Partner Steve Kraus, and leading digital health strategic counsel Fenwick & West Partner Michael Esquivel, as they look back on the past six months and look forward to the future of the market.

Note: This podcast was recorded on 7/30, prior to the Teladoc acquisition of Livongo.

Unprecedented Funding in an Unprecedented Time

How can healthcare stakeholders reach and sustainably engage patients with innovative, 21st-century technology? Hear from three leaders—HealthTech4Medicaid Executive Director Adimika Arthur, and Rock Health portfolio company founders, Podimetrics CEO Jon Bloom and Arine CEO Yoona Kim—to discuss the lessons they’ve learned in building solutions for high risk, high-cost populations. From diabetic veterans to Medicaid enrollees, they’ll share tactical tips in leveraging technology to lower the barriers to care for patients who need it most. Join the conversation to hear how they’ve found success in scaling these solutions with a digital-first, patient-centric mindset.

Lowering Barriers to Care With Digital Strategies That Scale

At Rock Health, we’re proud to fund and support entrepreneurs working at the intersection of healthcare and technology, and work alongside a diverse group of enterprise leaders making healthcare massively better—always, but especially now. We need collaboration as a rising tide to lift all boats—especially as the COVID-19 crisis accelerates trends reshaping healthcare as we know it.

Rock Health President Tom Cassels recently sat down with Advisory Board Senior Research Partner Amanda Berra, Accenture Senior Managing Director Darryl Jue, and ZS Managing Prinicpal Pete Masloski. They discuss what’s next for healthcare in light of COVID-19, and how industry leaders must adapt to the forces that will become more prominent and pervasive in the post-pandemic world.

The Current State of Digital Health Regulation

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