Legal Implications of Telemedicine

Conceptually telemedicine can effectively solve many challenges that are facing the healthcare industry today. Telemedicine overcomes distance & time barriers between health-care providers, can really solve the problem on unavailability of physicians in underserved areas and reduce the cost of healthcare. 

Despite its promise, telemedicine applications have not achieved significant levels of success and are yet come into the mainstream. In both developed and developing countries, telemedicine has yet to be consistently employed in the health care system to deliver routine services, and few pilot projects have been able to sustain themselves once initial seed funding has ended.

Legal considerations and lack of clear guidelines are a major obstacle to telemedicine uptake. These include:

• An absence of a clear national as well as international legal framework to allow health professionals to deliver services in different jurisdictions; `
• Overlapping, inconsistent and inadequate legal and regulatory frameworks, as well as the repertoire of standards imposed by state governments and professional organizations.
• Lack of policies that govern patient privacy and confidentiality vis - à-vis data transfer, storage, and sharing between health professionals and jurisdictions;
• Health professional authentication; and
• The risk of medical liability for the health professionals offering telemedicine services

While there is a proliferation of apps for tele-consultation, as recently as in July 2018 many practitioners were driven into frenzy about the illegality of telemedicine due to a Bombay high court ruling of in the case of Deepa Sanjeev Pawaskar And Anr vs The State Of Maharashtra on 25 July, 2018. However, an examination of the case facts reveals that medical negligence was established clearly in this case. The panic among the medical community is evidence of lack of clarity on this subject.

So, what does it take to have a legal and effective tele-medicine operations? The answer really lies in the question – what does it take to have an effective medical diagnosis done? Hence good clinical practices, duty of care of the doctor and establishment of doctor patient relationship are important for tele-medicine to be effective.

•  Substitute for physical examination – good clinical practices dictate that the doctor examines the patient before making the diagnosis. In a tele-medicine scenario, the same diagnosis can be done if the basic vital tests are conducted and results available for the physician to view while consulting with the patient. 
• Assisted tele-medicine – the presence of an assistant who can help the doctor with the examination and diagnosis is an added advantage 
• Video consultation – doctor being able to see the patient than a telephonic consultation is better from a clinical practice point of view 
• Adherence to data protection laws under IT Act and Data Protection Act – not just tele-medicine service providers but all EHR services must adhere to these guidelines.
• Hence providers must integrate good clinical practices, standard of care, data privacy guidelines, guidelines for non-repudiation/ authenticity of online transactions. Some of the scenarios that telemedicine service providers should avoid are:
• Suggesting treatment based on a questionnaire filled in by the patient or questions asked based on an online chat conversation
• Treatment on the basis telephonic conversation without examining the patient’s physiological characteristics
• Sharing of SPDI (patient data) with other parties who are unrelated to the treatment of the patient
• Storing of data in a non-secure manner
• Refusal to share patient’s own data with himself. Under the data protection bill data owner is the patient and he cannot be refused access to his data

Ultimately, it is about good medical practice and caring for patient than technology and the service providers should think about the same ethical issues with telemedicine that have always been considered in the medical profession. Physicians should use their professional judgement for the appropriateness of telemedicine usage for the specific medical scenario.

With a focus on duty of care, strong patient-doctor relationship, protecting patient privacy, promoting equity in access and treatment, and seeking the best possible outcomes, telemedicine can enhance medical practice and patient care in ways that both medical profession and regulators can comfortable with.
The Ministry of Health & Family Welfare is working on formulating specific guidelines under National eHealth Authority (NeHA) and Digital Information Security in Healthcare Act, which are expected to provide further clarity on this matter.

Shivakumar Krishnamurthy

Co-Founder Medi360

The blog is an excerpt from the accepted thesis “Telemedicine in India – Issues, Risks and Mitigation, A critical legal analysis of the implication of utilizing technology for remote healthcare services” for the PGDMLE coursework at National Law School of India University.