March 31st, 2022


Jacqueline Ward,
White House Office of Science and Technology Policy (OSTP)

RE: Request for Information on Strengthening Community Health Through Technology

On behalf of the California Life Sciences (CLS), thank you for the opportunity to provide input about how digital health technologies are used, or could be used in the future, to transform community health, individual wellness, and health equity.

CLS is privileged to be the statewide public policy association representing California’s innovative life sciences sector, with a membership spanning biotechnology, pharmaceutical, medical device and diagnostics companies, venture capital firms, research universities and institutes, as well as our sector’s nearly 350,000 California employees.

Our state’s innovative life sciences companies are vital to the development of groundbreaking therapies, devices, and diagnostics that offer cutting edge tools to diagnose and treat patients in need. We very much appreciate the Administration’s recognition that California’s innovators have been working around the clock to combat the COVID-19 pandemic and that they played a vital role in our collective fight against this virus through the development of new devices, diagnostics, therapeutics, and vaccines. Many of these tools incorporated connected health technologies.

CLS applauds the actions taken by this Administration to encourage, accelerate, or create novel coverage pathways for and in many cases, the production of, new and innovative medical devices, diagnostics and other treatments during the early stages of the pandemic.

The medical technology industry responded to the COVID-19 pandemic by adapting to customer and patient needs, including use of AI, smart connected devices, and intelligent devices. These can transform healthcare and the delivery of care while spanning across care settings, from connected medication management systems with smart devices in hospitals, to automated microbiology labs with robotics, portable point of care treatment and diagnostic solutions, to over the counter digitally read rapid COVID-19 testing done in the comfort of one’s home.

Increasingly, sensors and digital biomarkers are also being incorporated into the design of clinical trials for pharmaceuticals, enabling decentralized and hybrid trials incorporating home visits, reducing the burden on patients participating in clinical trials, and accelerating clinical timelines. Digital biomarkers to remotely monitor patient health are being validated by feasibility studies with the intent to incorporate them into clinical trials and patient care.

Multiple commercialization pathways now exist for digital health tools, providing more opportunities to realize an economic return on investment for tools supported by robust evidence and user demand. However, the need to modernize Medicare coverage of digital health technologies is a critical component for continued innovation.

Four broad commercial models are now in place and being used to generate payment or reimbursement for digital tool developers: direct-to-consumer, value-based contracting, “device-like” reimbursement, and “drug-like” reimbursement models. Digital health had been slowly becoming part of the therapeutic paradigm alongside traditional medicines before COVID-19, and this process has been significantly accelerated by regulatory agencies adapting to unprecedented times. For instance, U.S. Food and Drug Administration (FDA) recognized that digital therapeutics could provide value in addressing mental health and wellbeing during quarantine and isolation, and waived some requirements to enable their distribution and use.

For a robust overview of the innovation, evidence, regulation, and adoption of digital health trends, this 2021 IQVIA Institute report covers many aspects of the information requested.

As noted by Commissioner Dr. Califf in a recent update to the FDA technology and data modernization plan, “Technology and data have disrupted our world in ways unimaginable only 20 years ago – including how the world thinks about health. How we integrate new technology into medical product application reviews and food safety efforts, to facilitating the use of data insights to help treat disease, technology and data are ubiquitous in the work of the FDA.”

Continued engagement with regulators and policy makers is critical to the future success of digital health adoption. In addition to streamlined regulatory processes for digital health solutions and promoting RWE-based approvals, regular collaboration between life sciences organizations and FDA representatives would enable the development of forward-thinking regulations for new technologies and capabilities as they arise.

Given the request by OSTP to limit responses to three pages, we would also point to the recent World Health Organization Global Strategy on Digital Health, and a report on “Transforming healthcare with AI” by the European Institute of Innovation and Technology (EIT) and the McKinsey Center for Government. Both address critical issues for connected healthcare in a global economy, and discuss frameworks for closing disparity and access gaps, as well as deeper dives into technological innovations driving more efficient diagnostic tools, imaging systems, and clinical decision support.

Limited availability of skilled talent is a challenge facing most digital health players. Partnerships between life sciences organizations and academic institutions will help fast-track education in digital health. Rotational internships, or co-op programs, are another route through which life sciences organizations can introduce high-potential students to their sector before completing their degrees—giving them an opportunity to explore interests in digital health and presenting an alternative to the programs already being used by the larger technology companies to attract top young professionals.

Like most life sciences innovation, digital health solutions need the cross-pollination of ideas.

Because of the breakneck pace of innovation in digital health, employee skillsets need to be kept up to date, but we must also maintain the ability to learn from the COVID-19 pandemic and adequately protect against future public health threats. The establishment of antimicrobial stewardship programs covering all settings of care in order to reduce antimicrobial overutilization and the emergence of resistance (AMR) is crucial to this effort and critical diagnostic and surveillance technologies will play key roles.

California is home to more than 1,900 medical device and diagnostics companies, providing over 84,000 jobs across the state1. Our state’s innovative medical technology companies are vital to the development of groundbreaking devices and diagnostics that offer cutting edge tools to diagnose and treat conditions like cardiovascular disease, chronic pain, kidney and liver disease and diabetes.

CLS strongly supports the Biden Administration’s recent announcement reinvigorating the Cancer Moonshot and the spirit of public-private partnerships embodied in an effort designed to harness vast expertise across so many fields to reach the ambitions goals of finding impactful treatments and an end to cancer as we know it today.

Exponential progress is being made in screening and detection, earlier diagnosis, prevention, equity, treatment, and support for oncology patients. Greater application of digital health solutions has the potential to raise the level of care across other disease states, and successfully use digital health technology to deliver healthcare, enable healthier lifestyles, or reduce health disparities.

On behalf of the diverse and innovative California life sciences companies that make up our membership, thank you for the opportunity to respond to this RFI. Life sciences companies have the unique opportunity to leverage digital solutions to treat the whole patient across the entire patient journey and deliver better health outcomes, forever changing the care paradigm and adding immense value to the healthcare delivery system and to society as a whole.

Please do consider us a resource moving forward and we appreciate your attention to this matter.

Thank you,

Oliver Rocroi Vice President – Federal Government Relations and External Affairs
E. [email protected]