Telehealth raises a number of legal concerns, especially regarding cross-state practice and reimbursement. This module addresses many of the legal and regulatory issues affecting telehealth. However, it does not address reimbursement. There is a separate module for reimbursement in the Telehealth Toolkit. This module is not intended to be a comprehensive analysis of the legal issues but to highlight some of the more prominent legal issues that arise when using telemedicine technologies. Unfortunately, the resolution of some of these legal issues has not kept pace with advancements in the telemedicine field.
View each section of this module by topic, at right »
Licensure authority defines who has the legal responsibility to grant a health professional the permission to practice their profession. Historically, under Article X of the U.S. Constitution, states have the authority to regulate activities that affect the health, safety, and welfare of their citizens including the practice of healing arts within their borders (1).
The Federal Anti-Kickback Statute is designed to protect patients and federal health care programs from fraud and abuse by inhibiting the use of money to influence health care decisions. The law plainly states that anyone who knowingly and willfully accepts or offers remuneration of any sort and in any manner intended to influence the referral of Medicare and Medicaid services can be held accountable for a felony (14).
The Federal Physician Self-Referral Law, commonly known as the Stark Law, prohibits a physician (or an immediate family member of such physician) from referring Medicare patients to entities providing designated health services if that physician, or the physician’s immediate family member, has a financial (ownership, compensation or investment) interest in the entity. A practitioner must follow the Stark regulations if federal healthcare programs reimburse any of the referrals for designated health services.
Under the False Claims Act, those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds will subject the person submitting the claim to liability (30).
What is the FDA’s role in regulating Telemedicine?
The U.S. Federal Food and Drug Administration (FDA) plays a critical regulatory role in ensuring the safety and effectiveness of telemedicine medical devices and software with the Center for Devices and Radiological Health (CDRH) acting as lead agency. The Center is responsible for ensuring the safety and effectiveness of the medical devices used in telemedicine systems.
The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 (Pub. L 104-191). Congress sought to streamline electronic health record systems while protecting patients, improving health care efficiency, and reducing fraud and abuse (34). The HIPAA Administrative Simplification provisions required the Department of Health and Human Services to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers.
Telepharmacy is the integration of pharmacy software, remotely controlled dispensing cabinetry and telecommunications technologies to enable the provision of pharmaceutical services from a distance. Telepharmacy expands access to quality health care to communities nationwide, primarily in rural, medically-underserved areas (36).
Antitrust laws seek to promote fair competition on the merits and to protect consumers and businesses from anti-competitive business practices. Antitrust policy in the United States is based on the proposition that competition among companies results in lower prices, better products, and greater consumer choice. The antitrust laws seek to promote such competition by preserving the ability of consumers to take their business elsewhere when a particular company does not meet their desires.
Medical malpractice is a deviation from the accepted standards of practice in the medical community and causes injury or death to a patient for whom the physician has a duty of care. Medical liability is generally governed by State law. Standards and regulations for medical malpractice vary by State. Medical professionals are required to maintain professional liability insurance to offset the risk and costs of lawsuits based on medical malpractice.
