Telemedicine legal and regulatory issues are complicated by the fact that there are numerous legal definitions of telemedicine.
CMS defines telemedicine as the provision of clinical services to patients by practitioners from a distance via electronic communications.
ATA defines telemedicine as the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status. This definition says nothing about the need for clinical services.
JCAHO defines telehealth as the use of electronic information and telecommunication technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration. JCAHO defines telemedicine as the use of medical information from one site to another via electronic communications to improve patients’ health status. JCAHO considers telemedicine a subset of telehealth.
California has yet a different definition of telemedicine in AB 415, the Telehealth Advancement Act of 2011.
Information consultations between practitioners, telephone conversation, email or IM, or fax, are not telemedicine in California.
Adding to the epistemological chaos, telemedicine can be: (1) non-simultaneous (such as radiology services), or (2) simultaneous (“real-time”).
When you are developing a mobile app that involves exchange of healthcare information, an online health and wellness platform involving healthcare data, or another telemedicine or telehealth (or telepsychology / telepsychiatry) project, there are numerous legal and regulatory issues to consider.
As noted, telemedicine legal rules vary widely by state.
As well, the Food and Drug Administration (FDA) has draft guidance on mobile medical applications for telemedicine health applications on smart phones.
If you are a hospital interested in credentialing telemedicine practitioners, the CMS rule is particularly relevant.
CMS’s July 5, 2011 telemedicine rule allows hospitals and critical access hospitals (“CAH”) to rely on the credentialing and privileging decisions of another (distant site) hospital or another telemedicine entity.
CMS distinguishes the distant-site hospital (which is providing the services), and the distant-site telemedicine entity. The latter may not necessarily be Medicare participating. There must be a written agreement between the two entities that includes, among other things, a compliant credentialing plan, and, agreement that the hospital that credentials and privileges the distant-site practitioner shares the practitioner’s performance review information with the distant-site hospital. The regulations are easier for a distant-site telemedicine entity, which makes sense because such an entity is itself less regulated than a Medicare-participating hospital.
Thusm telemedicine legal compliance efforts should include:
- Drafting appropriate provisions for telemedicine credentialing and privileging in medical staff bylaws and policies, to ensure compliance with the CMS rule.
- Drafting appropriate telemedicine agreements (including with respect to credentialing and privileging).
- Complying with HIPAA and state privacy and security laws and regulations.
- Monitoring the performance of providers, and sharing review results as called for by CMS.
Written agreements for telemedicine credentialing and privileging should be well thought out and should include, for example, representations and warranties regarding the quality of services to be provided by the distant-site entity and providers and any of their subcontractors. (Note: this is especially important given privacy and security concerns, as HIPAA now imposes liability on the covered entity for acts of business associates who are considered agents. Quality of care considerations are also important from a liability standpoint, given vicarious liability.). Indemnification provisions are also key.
Apart from CMS requirements, states impose their own laws. For example, practitioners may need to obtain a telemedicine consent from patients in order to provide telemedicine services.
Contact the Cohen Healthcare Law Group’s telemedicine legal team for legal advice and counsel concerning telemedicine regulations.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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