Mobile healthcare technology allows doctors and patients to connect in a virtual patient waiting room. Telemedicine, as many call it, has benefits as well as burdens on everyone involved. There are several state and federal regulatory operations, laws and policies overseeing the use of mobile health technologies. Not only users, but also providers of mobile healthcare technologies should be aware of laws and regulations to make sure they deliver healthcare services consistent with laws and policies.
When healthcare services regulations are not satisfied, the agencies charged with enforcement can get involved. Here in Illinois, the Illinois Department of Financial and Professional Regulations (“IDFPR”) and the Illinois Medical Disciplinary Board can be involved in the investigation of complaints, which can lead to the suspension or revocation of a healthcare provider’s license to practice. Other agencies can get involved in a process leading to financial penalties and media coverage of negative occurrences.
Telemedicine practice can be within the oversight of the FDA, HIPAA, FTC, and the IDFPR.
FDA regulations protect patients from harm from mobile medical devices and applications. On February 9, 2015 the FDA published, Guidance for Industry and Food and Drug Administration Staff, defining types of medical devices, mobile apps, mobile medical apps and examples of how the FDA enforces its regulations. The FDA aims to guide and make nonbinding recommendations, not imposing legally enforceable responsibilities, in the above-linked document.
HIPAA rules, enforced through the Department of Health and Human Services (and state level laws), such as the Breach Notification Rule, Security Rule and the Privacy Rule affect mobile health industries. Applying these rules to telemedicine scenarios requires encryption methods, for example, to prevent rule violations, related fines, and negative public attention. Privacy and security concerns are addressed in the Department of Health and Human Services in, Your Mobile Device and Health Information Privacy and Security. A lost mobile device is the first item on the list of risks.
FTC protections keep consumers aware of fraudulent, deceptive and unfair business practices. In telemedicine the FTC rules most often apply to consumer information disclosures contrary to stated policies and regulations. The fines for violating FTC rules may be significant and a breach of duties could upset other users of mobile healthcare apps if their information is inappropriately transmitted to third parties. The FTC document, Complying with the FTC’s Health Breach Notification Rule, explains how the rule requires a notification be sent to groups of users in the event of a security breach.
IDFPR and similar professional licensing agencies are concerned with healthcare professionals practicing medicine and treating patients outside territorial jurisdictions. A doctor in Illinois practicing medicine in giving service to a patient in Indiana involves licensing regulations in both states. A National Practitioner Data Bank, used among the states, identifies licensee discipline and reports of medical malpractice decisions and settlements in one state that could flag other states to make independent license inquiries.
Michael V. Favia & Associates are available to assist with analysis and advice on difficult mobile healthcare practice matters. With offices conveniently located in the Chicago Loop, Northwest side and suburban meeting locations, you can schedule a discrete meeting with an attorney at your convenience and discretion. For more about Michael V. Favia & Associates’ professional licensing work, please visit www.IL-Licensing.com and feel free to “Like” the firm on Facebook and “Follow” the firm on Twitter.