Health care providers and other entities face a host of legal and practical challenges as they implement telehealth and telemedicine initiatives.

For example, providers of telehealth services, and the entities creating or hosting telehealth platforms, must determine which federal and state privacy and security laws apply to them.  These laws, such as the federal Health Insurance Portability and Accountability Act (HIPAA), may impose privacy and security restrictions, as well as restrictions on the use of data for marketing.  Additional privacy and security complications may arise if providers choose to store data from telehealth encounters on the “cloud.”

Provider licensing laws also affect the provision of telehealth; these vary from state to state and may prevent providers from remotely treating patients in other states.  The Federation of State Medical Boards, a non-profit group representing state medical boards, is currently developing an Interstate Medical Licensure Compact which would expedite the licensure process for physicians looking to practice in multiple states, and would regulate which state medical board has jurisdiction over cross-border medical interactions.  Similarly, telehealth makes provider credentialing and privileging decisions more challenging.

Given the sometimes overlapping jurisdiction of federal and state agencies, there is also some uncertainty regarding which agencies will regulate and oversee various aspects of telehealth.  For example, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services enforces HIPAA.  The FDA’s Center for Devices and Radiological Health (CDRH) ensures the safety and effectiveness of “medical devices” used in telehealth systems.  Similarly, the FTC has become increasingly involved in the health care sphere and may use its authority to protect patients from “unfair or deceptive acts or practices”; the FTC has also asserted jurisdiction over certain health care data breaches.

Telehealth also raises novel questions regarding medical liability.  For example, it is unclear whether liability could attach to a failure to identify patterns flagged by remote monitoring technologies or in health-related apps used by patients.  Additionally, where providers treat patients in other states, it is not certain which state medical liability laws or standards of care will apply, and whether medical malpractice policies will cover suits arising from these interactions.

In addition to these legal and regulatory questions, practical considerations in telehealth expansion include gaps in broadband access, rapidly changing technologies, and the fact that telehealth may not easily fit into a providers’ current practice patterns.  Finally, reimbursement practices are inconsistent across public and private payers, making the financial viability of telehealth programs uncertain.

Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience…

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and health information privacy. Ms. Kraus regularly advises clients on Medicare reimbursement matters, the Medicaid Drug Rebate program, health information privacy issues (including under HIPAA and the HITECH Act), and the challenges and opportunities presented by the Affordable Care Act.

Photo of Paige Jennings Paige Jennings

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private…

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private sectors. Prior to earning her law degree and Master of Public Affairs, she worked in the U.S. Senate for over four years, advising Senators John Breaux and Tom Carper on health and social policy matters. Ms. Jennings later handled federal health policy issues at WellPoint, Inc. During law school, she worked with the U.S. Office of Management and Budget during consideration of the Affordable Care Act, and with the Federal Trade Commission for then-Chairman Jon Leibowitz.