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Law360 (December 22, 2020, 6:40 PM EST )
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| Megan Baca |
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| Kellie Combs |
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| Christine Moundas |
In particular, innovation and regulatory flexibility in the field of digital health technologies, including telehealth services and remote patient monitoring and therapeutics, allowed patients to receive ongoing care while minimizing the risk of COVID-19 exposure to both the patient population and health care providers.
Likewise, the increased use and availability of big data and analytical technologies has allowed regulators and the health care industry to access vastly more information. This has, in turn, spurred more rapid research, innovation, and development of medical technologies and therapeutics to address the pandemic, and provided a case study to support the value of such practices in the context of medical product development more generally.
Though the health care industry had been trending toward increased use of digital health technologies in recent years, their unique value in the context of the COVID-19 pandemic prompted more rapid, widespread adoption and has increased comfort with such technology among regulators, health care providers and patients.
In this article we take a look back at the digital health trends of the past year and recap the extraordinary developments of 2020.
Health Information Technology
The use of digital health technologies in care delivery expanded significantly in 2020, as the COVID-19 public health emergency required reduced in-person interaction in order to curb the spread of the disease. In particular, 2020 witnessed significant developments in telehealth, interoperability and health information exchange, and medical device software.
Telehealth
The number of virtual visits under Medicare and Medicaid rose from 13,000 per week prior to the public health emergency to almost 1.7 million per week after the public health emergency began.[1] The number of telehealth services and procedures billed under commercial health insurance plans also rose significantly, representing an 8,336% growth between April 2019 and April 2020.[2]
Federal and state regulators temporarily waived regulatory barriers that previously limited the remote delivery of care, which further accelerated this trend. The Centers for Medicare and Medicaid Services introduced Medicare reimbursement for new telehealth services and has indicated some of these services will remain reimbursable in the future.
Similarly, many states that introduced new flexibilities for telehealth during the public health emergency are exploring permanent expansion of reimbursable telehealth services under their Medicaid programs and requiring commercial insurers to offer reimbursement parity to providers for services provided via telehealth.
Interoperability and Health Information Exchange
In early 2019, CMS and the Office of the National Coordinator for Health Information Technology proposed rules to implement interoperability and patient access provisions of the 21st Century Cures Act to facilitate the access and exchange of electronic health information. Despite the public health emergency, both agencies released final rules regarding these provisions in 2020.
Although the final rules specified initial effective dates in 2020 for certain requirements, the agencies subsequently extended many of these deadlines as the burdens of the public health emergency on the health care industry became increasingly apparent.
Although the enforcement of these rules may have taken a back seat in 2020, we expect them to resurface in 2021 as the public health emergency subsides. Requirements that will take effect in 2021 include the following:
- Information blocking, applicable to health IT developers, providers, health information exchanges and health information networks, on April 5;
- Electronic admission, discharge and transfer notifications, required for Medicare-enrolled hospitals, on May 1;
- Patient access application programming interface, required for Medicare Advantage, Medicaid, Children's Health Insurance Program and qualified health plan insurers, on July 1; and
- Provider directory application programming interface, required for Medicare Advantage, Medicaid and the Children's Health Insurance Program, on July 1.
Medical Device Software
2020 has seen continued growth in the medical software space, particularly in areas that are relevant to responding to the COVID-19 public health emergency, such as software focused on remote patient monitoring.
This growth has been spurred in part by the U.S. Food and Drug Administration temporarily relaxing regulatory requirements — most notably, the requirement for marketing authorization — relating to the distribution and use of certain low-risk categories of remote health care devices.
These include, for example, marketing of certain digital therapeutics for treatment of psychiatric disorders without clearance or compliance with other reporting requirements; distribution and use of remote digital pathology devices without clearance; and modifications to the indications and software or hardware of noninvasive remote monitoring devices to allow for remote monitoring and/or home use without FDA clearance.
Though these policies are expressly limited to the time of the emergency, the FDA's guidance documents leave open the question of how regulators will approach engaging with products marketed under the policies once the emergency ceases, particularly in the case of digital therapeutics that have been placed directly into the hands of consumers.
The FDA's risk-based approach to digital health during the pandemic is in many ways consistent with its prepandemic approach, with some additional flexibility in specific areas relevant to the public health emergency.
Though the FDA had previously indicated an intention to work in 2020 toward clarifying and finalizing draft policies related to its regulation of digital health software technologies, other regulatory priorities necessitated by the COVID-19 public health emergency forced the FDA to focus on more reactive, short-term actions instead.
However, the FDA turned its attention back to digital health more broadly with its September launch of the Digital Health Center of Excellence, a central resource intended to help the agency and external stakeholders build partnerships to accelerate digital health advancements and share knowledge to promote innovation in digital health development and regulation.
In addition, the FDA's Center for Devices and Radiological Health list of guidance priorities for 2021 includes both finalizing its current draft guidance on clinical decision support software and issuing draft guidance on artificial intelligence and machine learning tools. As the FDA's approach to digital health software continues to evolve, it will be critical for companies developing digital health tools to stay abreast of FDA regulations and guidance.
Big Data in Medical Research and Development
Over the last several years, health IT companies, health care providers and payors have increasingly partnered to conduct analyses utilizing large databases containing data from sources like medical claims, user data, and electronic health records as well as clinical and nonclinical research and molecular information.
Big data holds great potential for developing novel pharmaceutical drugs, medical devices and health care treatment plans. Digital health aspects of using big data involve both the technology for compiling and sharing sizeable datasets containing information from a variety of sources, and the AI and machine learning tools that can unlock new insights from the datasets.
Data Sharing
Generally, larger datasets are more advantageous because they provide larger sample sizes that can provide more statistically significant and precise metrics than smaller datasets. In order to collectively benefit from larger datasets, health companies increasingly have been pooling their datasets in data sharing initiatives.
These data sharing initiatives allow health systems, research institutions, companies and others to contribute to a larger pool of data, in turn receiving greater insights into patient health and treatments or the opportunity to more closely study rare or unique diseases.
There are a number of unique transactional considerations that companies considering these types of data sharing arrangements should keep in mind. For example, contractual provisions in these data sharing agreements should address the rights of the contributors to the pooled data and derivatives thereof.
Key considerations include whether contributors are permitted to retain any of the underlying raw data used to develop insights and inferences from the data pool, and whether there are any royalty sharing obligations for algorithms and insights that individual contributors develop and commercialize from the joint pool.
AI and Machine Learning
AI and machine learning tools use sophisticated computer algorithms to identify and unlock complex and subtle patterns embedded within large datasets. Companies can use these insights to identify promising drug candidates for synthesis and testing, and for developing effective treatments tailored to specific patient profiles.
In 2020, multiple collaborations have brought together the knowledge and developmental resources of traditional institutions in the health care space with the expertise of startups and other technology providers that offer AI platforms but who do not have the infrastructure to otherwise shepherd a drug candidate through the development and marketing authorization process.
The value of AI systems is based on proprietary algorithms and models developed by the platform provider, and from training of the algorithm on datasets provided by partners.
Key considerations for companies entering into data collaborations include whether the dataset owners retain any rights to the improvements or training of the AI platforms after the completion of the engagement, and whether the AI platforms can retain the training obtained from the customer dataset.
For example, some customers with sizeable datasets may be concerned that competitors with smaller datasets may benefit from future engagement with the AI platform, in part based on the training using the customers' datasets.
Privacy Considerations
As access to and use of big data has increased, contractual provisions in data sharing initiatives and collaborations in the digital health context must address obligations arising from regulatory compliance. The ever-evolving privacy landscape, including new laws such as the California Consumer Privacy Act, may impact what primary and secondary data uses parties can agree upon depending upon the origin of the data and the relevant regulatory overlay.
Further, platform providers and their customers also wrangle with negotiated indemnities against costs of data breaches and government enforcement. The terms of such indemnities may vary based on the nature of the AI platform. For example, if the AI platforms retain any identifiable patient health data as part of its models, the indemnity obligations may last for a longer term.
Contributors to data pools and customers of AI platforms should also be mindful of whether they have appropriate consents to share identifiable patient protected health information. Even when a data pool consists of only de-identified treatment information, the participants, and platform providers themselves, may still be contractually prohibited from reidentifying any of the information within the pool or attempting to do so.
Similarly, even when some big data platforms have purportedly used de-identification of patient health data in order to limit their compliance with the Health Insurance Portability and Accountability Act, some customers have sought assurances of HIPAA compliance.
Real-World Evidence in Drug Development
One application of big data receiving a lot of focus in recent years has been the utilization of real-world evidence, from sources like medical claims, registries and electronic health records, in drug development.
Real-world evidence received a significant boost under the 21st Century Cures Act in 2016, which required that the FDA establish a program to evaluate its potential use to support approval of new drug indications and to help satisfy post-approval study requirements.
The Cures Act also required the FDA to issue a draft framework for real-world evidence, which the agency did in 2018. Despite these advances, uptake of real-world evidence in drug development has been slow due to limited agency comfort and lack of clear guidance for its use.
As a result of the COVID-19 public health emergency, the FDA, other regulatory authorities and industry have heavily relied on real-world evidence to understand COVID-19 and to assess potential treatment options.
For example, in May, the FDA launched a real-world evidence-focused research project in collaboration with the health IT company Aetion Inc. to study the use of diagnostics and medications during the COVID-19 public health emergency and to identify risk factors for COVID-19-related complications.
Also, in August, the Perelman School of Medicine at the University of Pennsylvania announced its participation in an international consortium of research scientists seeking to pool electronic health record data from around the world to discover clinical insights about COVID-19.
The FDA has also been using its own Sentinel System, a large multisite distributed database dedicated to medical product safety and surveillance, to assess COVID-19 drug use and shortages and to conduct natural history and treatment impact studies.
FDA Commissioner Stephen Hahn has expressly recognized the importance of real-world evidence in the COVID-19 public health emergency response and has noted that the agency will consider recent real-world evidence innovations and adaptations as it moves forward more generally with its policymaking on real-world evidence.
Of note, as required by the 21st Century Cures Act, the FDA is expected to release guidance by the end of 2021 addressing standards, methodologies and circumstances under which sponsors can rely on real-world evidence.
Companies considering employing real-world evidence approaches as part of drug development should carefully consider evolving regulatory guidance in this area and work closely with the FDA or other applicable regulatory authorities beginning early in drug development.
Conclusion
Big data tools and digital health software, both of which had been increasingly integrated into routine health care delivery and drug and device development in years past, proved to be uniquely valuable tools in the global response to the COVID-19 public health emergency.
Faced with unprecedented challenges, regulators and providers increasingly engaged with these technologies in 2020. Ultimately, the willingness of regulators, providers and industry to embrace health IT platforms spurred innovation as part of the focused, global effort to mitigate COVID-19's global impact.
Though much of the regulatory flexibility in digital health in 2020 has been specific to the context of the COVID-19 public health emergency, the legacy of increased comfort among regulators, providers and patients with the use of digital health technologies may accelerate their development and uptake in the years ahead.
Megan Baca, Kellie Combs and Christine Moundas are partners at Ropes & Gray LLP.
Sarah Blankstein, William Ognibene, Gideon Palte, Michael Purcell and Shong Yin, associates at the firm, contributes to this article.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Eric Wicklund, CMS: 9 Million Used Telehealth During Early Days of COVID-19, mHealth Intelligence (Jul. 16, 2020), https://mhealthintelligence.com/news/cms-9-million-used-telehealth-during-early-days-of-covid-19.
[2] Telehealth Claim Lines Increase 8,336 Percent Nationally from April 2019 to April 2020, PR Newswire (Jul. 7, 2020), https://www.prnewswire.com/news-releases/telehealth-claim-lines-increase-8-336-percent-nationally-from-april-2019-to-april-2020--301087477.html#:~:text=NEW%20YORK%2C%20July%207%2C%202020,Health's%20Monthly%20Telehealth%20Regional%20Tracker.
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