NEW DELHI: The National Medical Commission (NMC) has said that there is “no prohibition” against remote review and authentication of lab reports, discharge summaries and other electronic clinical documents by a Registered Medical Practitioner through a digital signature.
However, it clarified that remote authentication should be undertaken only after the concerned RMP has reviewed the relevant clinical information, records, investigations and other material necessary for forming the professional opinion and has exercised independent professional judgment in determining whether the report is authentic.
“Where the available information is inadequate for forming such professional opinion, the RMP shall refrain from authentication until such further information, examination, verification or review as may be professionally required has been undertaken,” an advisory issued by the NMC said.
The clarification from the NMC regarding remote authentication of medical records through Digital/Electronic Signatures has come in view of the widespread use of telemedicine, which has made healthcare facilities accessible to people even in the remotest corners of India.
The advisory stressed that digital signatures, electronic signatures, signature creation data, authentication credentials, access tokens or other authentication mechanisms used for the authentication of medical records shall remain under the control of the concerned RMP and shall not be shared, disclosed, delegated, transferred or knowingly made available to any other person.
“The concerned RMP shall exercise reasonable care to prevent unauthorised access to or use of such credentials. Any suspected compromise or unauthorised use shall be promptly reported in accordance with applicable institutional and legal requirements, and appropriate corrective measures shall be undertaken,” the NMC warned.
It also clarified that if a foreign medical expert provides a remote consultation or second opinion to an Indian healthcare establishment, such an opinion may be considered by the treating team in accordance with applicable law.
The identity, professional qualifications, professional registration/licensure, date and nature of the consultation, and the professional opinion provided by the foreign medical expert shall, to the extent applicable, be appropriately documented as part of the patient's medical record.
“Such consultation or opinion shall not, by itself, constitute authorisation or certification of an Indian medical record by the foreign medical expert or confer any right to practise medicine in India,” the advisory added.
It also said that the advisory shall not be construed as permitting independent medical practice in India by persons who are not authorised to practise under the NMC Act, 2019, nor shall it be construed as recognising foreign medical registration for such purposes.
The advisory, issued on October 13, also said that healthcare establishments shall ensure that electronic records are maintained with appropriate security measures, audit trails, authentication logs, date and time stamps, and other safeguards to preserve the integrity, confidentiality and traceability of electronically authenticated medical records.
Healthcare establishments shall retain electronically authenticated medical records and related authentication and audit logs for the period prescribed under applicable law.
“They shall also ensure compliance with applicable requirements relating to data protection, privacy, information security and cybersecurity, including requirements concerning the processing, storage, transmission, access, confidentiality and protection of personal health information,” it suggested to healthcare institutions.
It noted that divergent practices have evolved across healthcare establishments, resulting in uncertainty regarding the remote review and authentication of medical records and clinical documents, professional accountability, adequacy of clinical information, security and integrity of electronic records, inter-State practice, cross-border consultations and other allied issues.
The NMC said the advisory has been issued to promote uniform implementation of the existing legal framework, remove ambiguity relating to remote authentication of medical records through Digital/Electronic Signatures, ensure patient safety, preserve professional accountability and facilitate the responsible adoption of digital healthcare technologies.
“It is clarified that there is no prohibition under the National Medical Commission Act, 2019, the Regulations framed thereunder or the Telemedicine Practice Guidelines, 2020, of EMRB, NMC, against the remote review and authentication of laboratory reports, pathology reports, radiology reports, diagnostic interpretations, discharge summaries and other electronic clinical documents by a Registered Medical Practitioner (RMP) through a Digital Signature or other Electronic Signature or electronic authentication technique recognised under the Information Technology Act, 2000, and the rules made thereunder, as applicable,” the advisory said.
It added that remote authentication shall be undertaken only after the concerned RMP has reviewed the relevant clinical information, records, investigations and other material reasonably necessary for forming the professional opinion, and has exercised independent professional judgment in determining whether the report, interpretation, summary or other clinical document is appropriate for authentication.
The use of a Digital/Electronic Signature shall constitute only the mode of authentication of an electronic record and shall not dispense with or diminish the professional, ethical or legal responsibility of the RMP authorising such a report, and shall not absolve the individual or organisational responsibilities arising under the applicable laws, rules and regulations.
It further added that authentication of a report shall not be construed as approval of, or as dispensing with, any process, examination, verification or professional review otherwise required under applicable law or professional standards, and shall not be used to bypass or substitute the independent professional judgment of the concerned RMP.
An RMP authorised to practise under the NMC Act, 2019, may remotely authenticate reports generated by a healthcare establishment with which the RMP is duly appointed, empanelled, contracted or otherwise professionally associated, in accordance with applicable law, provided that such remote authentication is undertaken in the course of the RMP's lawful professional engagement and the RMP has lawful access to the relevant clinical records, it said.
“Nothing in this advisory shall be construed as conferring any independent right to practise medicine, or as dispensing with any requirement relating to registration, licensing, appointment, jurisdiction or professional practice applicable under any law.”
The NMC said that the rapid advancement of digital healthcare technologies, including Hospital Information Systems (HIS), Electronic Medical Records (EMR), Electronic Health Records (EHR), Laboratory Information Systems (LIS), Radiology Information Systems (RIS), Picture Archiving and Communication Systems (PACS), telemedicine platforms and other digital health solutions, has significantly transformed the manner in which healthcare services are delivered across the country.
These technologies enable RMPs to remotely review, interpret and authenticate clinical information while ensuring timely and efficient healthcare delivery.
The High-Level Committee on Non-Financial Regulatory Reforms has also recommended facilitating the use of Digital and Electronic Signatures in medical practice in accordance with the Information Technology Act, 2000, with the objective of promoting ease of healthcare delivery, improving accessibility and reducing avoidable regulatory impediments, the advisory said.