The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control and Prevention has also recognized that technology and surveillance systems can play an integral role in supporting the public health response to outbreaks.

The following are just a few examples of how technology has the potential to play an integral role in flattening the curve, limiting the spread of the virus, and assisting in the treatment of infected individuals.  Perhaps the positive impact of these technologies will further accelerate the adoption and importance of digital innovation in healthcare.  However, such innovation still needs to be balanced with the continuing need for safety.

Tracking the Coronavirus Pandemic

Digital health technology can help manage the pandemic by providing an early signal to potential infection.  As widely reported, many public health authorities are limiting test eligibility to symptomatic patients and healthcare workers.  Furthermore, there is a time delay between the onset of physical symptoms and, if the infected individual is able to get a diagnostic test, the receipt of results.

Kinsa Health, a company that uses internet-connected thermometers, has provided smart thermometers to people to record fevers at home.  Users of the smart thermometer can then instantly report their fever and symptoms.  Though the thermometers cannot confirm that a person has the coronavirus, the fever spikes captured by the thermometer are an early signal to potential infection.

Data from the Kinsa thermometer could help health authorities plan their allocation of resources.  The instant reporting feature allows Kinsa to track the spread of fevers, and share the data through its online interactive maps that show where individuals are exhibiting symptoms by zip code.  The clusters of fever spikes can signal to health authorities where to allocate medical resources and where to impose measures to further prevent the transmission of the virus.

Monitoring Hospital Visitors and Patients

Artificial intelligence has also been implemented in hospitals in the United States and abroad to help medical professionals screen visitors and treat infected patients.  Hospitals with access to digital health technology can more effectively monitor and manage the coronavirus pandemic.  For example, in Florida, Tampa General Hospital is using artificial intelligence developed by Care.ai, Inc. to screen hospital visitors with camera-embedded facial scanners that analyze facial attributes and thermal scans to determine whether a visitor is feverish.  Similarly, researchers at the University of Massachusetts Amherst are developing FluSense, an artificial intelligence device intended to analyze cough sounds to assess the potential spread of viral respiratory diseases.  Hospitals are deploying tools like these to help reduce the spread of the virus.

Remote monitoring, another form of artificial intelligence technology, can be implemented by medical facilities to protect staff and carefully monitor patients.  In Israel, for example, Sheba Medical Center has been monitoring patients at remote hospital units in the hospital’s dormitories and underground parking garages.  The sensor technology employed by Sheba, developed by EarlySense Ltd., is positioned under the patient’s mattress and analyzes the patient’s heart rate, respiratory rate, and body movement.  Hospital staff can then monitor the patients remotely and be alerted to deteriorating health conditions as they occur.  This technology not only reduces the medical professional’s exposure to the virus, but also benefits patients by improving the quality of health care.

3-D Printing of Equipment and Materials

3-D printing has been recognized for its potential in crisis remediation, and we are seeing this with COVID-19.  The Chinese used 3-D printed houses for isolation of infected patients.  Facebook has a group, OSCMS, dedicated to the design, validation and sourcing of fabrication of open source emergency medical supplies.  Tips for using 3-D printing to create values and components for ventilators are being created by technologists and shared by healthcare professionals around the world via tools like Google Docs and WhatsApp.  There are various stories of short-term use ventilators being produced using 3-D printing techniques.

More Examples in China

The China Academy of Information and Communications Technology recently released a full report on the use of big data, AI and smart applications by more than 100 Chinese companies in response to the pandemic. The report concludes that collection and accumulation of data, harmonizing data standards and sufficient data processing capabilities were all key to a more successful response. Specific examples of digital technologies that are promoted by the report for epidemic prevention and control include: (1) “big data monitoring and analysis platforms to analyze the trajectory of confirmed patients, track their contact history, identify the virus transmission route, and predict the development trend of the epidemic situation”; (2) “AI technologies, … online diagnosis, viral genome sequencing” and (3) “cloud computing, big data, AI … applications in epidemic detection, analysis, early warning, prevention and control.”  Interestingly the report also talks about privacy and the importance of anonymization for data sharing even during a crisis.

Balancing Innovation and Safety

As we all struggle with the impacts of the crisis it is heartening to know that human ingenuity is a great source of solutions to our problems.  Perhaps fears with respect to the impacts and risks of technology in healthcare may have been disproportionate when compared to the very real benefits that technology is exhibiting in helping to manage the pandemic and attempt to curb the spread of the virus.  However, we have seen little discussion or coverage of whether these rapid innovations are taking into account regulatory guidance.  We make no comment on the compliance of any of the solutions described in this post, but instead observe that safety and compliance do remain important considerations even when moving rapidly.  As our colleagues posted yesterday, some simple steps can also help in managing litigation risk with these types of innovative technologies.  We have also developed a Coronavirus/COVID-19 Checklist to assist companies that are deploying technology solutions to manage the spread of the virus.

Photo of Nigel Howard Nigel Howard

For over 30 years Nigel Howard has specialized in technology transactions such as M&A, strategic alliances, licensing, distribution agreements and outsourcing. Clients range from start-ups and emerging companies to international corporations. He has led negotiations of billion dollar service agreements that were critical…

For over 30 years Nigel Howard has specialized in technology transactions such as M&A, strategic alliances, licensing, distribution agreements and outsourcing. Clients range from start-ups and emerging companies to international corporations. He has led negotiations of billion dollar service agreements that were critical to his client, and successfully handled the intellectual property and data issues on over 250 venture capital and M&A transactions.

Nigel is a “tremendous attorney” singled out for his detail-oriented approach, according to clients interviewed by Chambers and Partners. Peer commentators note his admirable commercial awareness, which achieves business-focused results, often in the most challenging of circumstances. He uses his extensive experience with IP and technology to advise on the commercial imperatives underlying these agreements.

Nigel has been ranked by Chambers Global, Chambers USA, Legal 500, Best Lawyers in America, and Who’s Who in American Law. He is frequent speaker on AI, data, distribution, and technology legal issues. His past and current clients include American Airlines, the American Bankers Association, American Express, AstraZeneca, British Airways, Brown Brothers Harriman, Cathay Pacific, Cisco, CoBank, DoubleClick, Etihad, HPE, Farelogix, Iberia, Mars, Merck, Merrill Lynch, Microsoft, NCR, the NFL, Novartis, P&G, Philippine Airlines, Promontory Financial, Singapore Airlines, Teva, TouchTunes, UBS, and Wyeth.

Read more about Nigel Howard
Show more Show less
Photo of Wade Ackerman Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade…

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.

Read more about Wade Ackerman
Show more Show less
Photo of Christina Kuhn Christina Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.…

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.

Read more about Christina Kuhn
Show more Show less