Telemedicine laws will change if the U.S. Congress enacts the “Healthcare Innovation and Marketplace Technologies Act” (“HIMTA”), a bill which seeks to establish the “Office of Mobile Health” within FDA, the federal Food and Drug Administration.
The Healthcare Innovation and Marketplace Technologies Act would create an Office of Mobile Health within the FDA.
This federal office would provide recommendations to the federal government on legal issues relating to medical mobile applications. Such recommendations would include ways to help ensure that software developers are creating secure coding that will enable the makers of the apps to comply with HIPAA, HITECH, and other medical privacy (confidentiality) and security laws and regulations.
Previously, the FDA had proposed that mobile medical applications on smart-phones be regulated as medical devices. See FDA regulates telemedicine on smart phones (discussing FDA draft guidance to regulate telemedicine via mobile app regulation).
The tricorder used on Star Trek would be regulated under this set of rules. And that is probably where we are heading.
At the moment, most telemedicine start-ups are creating online health education; a smaller subset is looking to extend diagnosis and treatment beyond the bricks-and-mortar office and into the online setting; and a smaller subset still, to expand practices beyond state lines. In so doing, the telemedicine companies face a variety of legal issues, including:
- compliance with standard of care obligations
- laws governing physician (and other practitioners’) licensure in both the home state and the remote state
- regulations governing telemedicine licensure (to the extent they exist)
- laws and standards governing requirement of a face-to-face, in person physical exam
- legal parameters relating to prescribing online
- other legal and regulatory issues
It is important to seek experienced telemedicine legal counsel before marketing any health informational, educational, or clinical enterprise that is Internet-based. Increasingly as we move into a virtual, online global society, old sets of legal rules still dominate the landscape. Contact the Cohen Healthcare Law Group for a telemedicine or e-health legal consult that fits your particular business.
Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets. As a corporate and regulatory attorney who has also handled litigation matters, Mr. Cohen represents conscious business leaders in a transformational era.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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