Digital Health and Health Information Technology

Information and communication technologies have great potential to connect clinicians and patients to provide accessible, convenient, quality care to patients—which have become essential during the COVID-19 public health crisis. Our Digital Health Team supports health care organizations as they set up telehealth and remote patient monitoring solutions. We advise clients on the continuously changing federal and state law related to telehealth, including coverage and reimbursement, corporate practice of medicine and other professions, privacy and security, scope of practice and licensure, patient consent, prescribing, and fraud and abuse laws.

There is a growing interest in directly engaging with consumers on management of their health and wellness. Innovators are developing technology that helps patients address their own health needs or monitor their health with or without the direct engagement with clinicians. These tools raise unique questions about scope of practice, reimbursement and business models, data use and disclosure, privacy and security, FDA oversight, consumer protection, liability, and considerations for partnerships with health care organizations. Our Digital Health Team works with companies to understand the regulatory landscape and how these technologies interplay with laws and regulations that did not contemplate health care tools outside of the provider clinical context.

At the core of digital health are tools that directly support care delivery, including electronic health records (EHRs), health information exchange services (HIEs), clinical decision support, predictive analytics and population health management technology. We advise clients on regulations and commercial agreements related to the adoption and use of these technologies; issues related to health data sharing, interoperability, patient access to data and information blocking prohibitions; oversight of technology by FDA for use in clinical practice; liability risk;  and IP.

Digital Health technology does not fit neatly within the FDA legal frameworks for other devices and raises liability questions.  Our Digital Health team is able to advise on FDA changes to support software as a medical device, including digital therapeutics, and machine learning (ML) and artificial intelligence (AI) technology. We also have deep experience on use of data to support the development of ML and AI-based medical devices. We have experience supporting commercial agreements for development of digital therapeutics and the unique considerations for these new technologies supporting patients.

Social determinants of health are conditions in the environments in which people live, learn, work, play, and worship that affect a wide range of health, functioning, and quality-of-life outcomes and risks. As health care organizations increasingly look to maintain healthy patient populations and manage care of individuals outside of acute health care services, there is a growing interest in supporting social services and a growing development of technologies that support social needs. We have advised clients on privacy and data sharing between health care and social care organizations, reimbursement and coverage, and interoperability and standards.

There is a growing need for data to support public health activities, including electronic case reporting (eCR), data analytics, contact tracing, and public health alerts.  We work with technology companies and organizations implementing public health technology strategies to consider state and federal issues regarding reporting and exchange of data for public health, data access and technology requirements.  We have advised on the interplay between public health reporting laws and privacy, data use and data sharing for public health purposes, including contact tracing, health information exchange and interoperability for eCR, and use of data analytics for public health purposes.

Research is changing due to new sources of real-world evidence and patient data, stemming from evolving technology and advancing analytics of extremely large data sets. Precision medicine research, spearheaded by government and advanced by life sciences companies and academic institutions, is leading to improved treatments and outcomes from personalized medicine. We advise life science companies and academic institutions on understanding who can access this data, which is based on compliance with privacy regulations, human subjects research protections and other research regulations, and how data registries can be established to support these initiatives. We have also advised technology companies on the creation and implementation of platforms that can assist with research-related data collection and use.

We help you navigate the regulatory requirements for data access, exchange, and interoperability between you and your users, health care providers, and other organizations such as health information exchanges, research institutions, and social services. This includes laws impacting sensitive behavioral health and substance use disorder data as well as complex issues related to minors and privacy.  We advise on compliance with health data laws that impact privacy, including HIPAA, HITECH, Part 2 regulations, 21^st Century Cures Act regulations, including information blocking regulations, other interoperability and patient access regulations, state privacy laws (including CMIA and CCPA), international privacy laws (including GDPR), and FTCA.

We help you to develop and deploy telemedicine and remote monitoring solutions that comply with legal and regulatory requirements, including licensure, antitrust, security, and payment issues.

We help you develop a commercialization model for Medicare and Medicaid and commercial insurance by advising on changing reimbursement rules and state coverage and parity laws to identify the to maximize your value to customers and help regulated entities meet their own requirements and incentives.  We identify fraud and abuse issues and solutions regarding business strategies and partnerships.

We work with clients establishing unique partnership arrangements and collaborations.  Our corporate and health care regulatory teams work collaboratively to negotiate corporate arrangements, licensing agreements, and establish lawful referral arrangements with other organizations.

We help you to protect internally developed tech innovations with a comprehensive intellectual property, FDA, and product risk management strategy. Our team can assist with patent, copyright and trademark issues that may be needed for your digital health innovation.

We help you consider legal issues related to promoting your digital health products and services by ensuring compliance with applicable policies for advertising, use of social media and marketing, and website policies and terms of use.

We provide strategic advice and support advocacy efforts to enable digital health innovators to drive critical policy change and educate policy makers on impact of laws and regulations. We monitor and advise on the impact of changing statutes, regulations, and guidance that impact digital health companies, at the federal, state, and local level – so you can be strategic, not reactive.