Can a doctor approve your test report without being physically present? NMC clarifies
The NMC clarification came amid differences in practice across healthcare establishments, which the commission said, created uncertainty around the remote review and authentication of medical records, professional accountability, and the security and integrity of electronic records.
Synopsis:The National Medical Commission (NMC) has clarified that registered medical practitioners can remotely authenticate diagnostic reports and other electronic medical records using digital signatures. The advisory requires doctors to review adequate clinical information, exercise independent professional judgement, maintain accountability and protect patient data, while prohibiting the sharing of signature credentials.
The National Medical Commission (NMC) on Tuesday, 13 October, clarified that registered medical practitioners can remotely review and authenticate laboratory reports, pathology reports, radiology reports, diagnostic interpretations, discharge summaries and other electronic clinical documents using recognised digital or electronic signatures, provided they comply with existing legal and professional requirements.
In a public notice dated 13 October, the NMC’s Ethics and Medical Registration Board said there was no prohibition under the NMC Act, 2019, the regulations framed under it or the Telemedicine Practice Guidelines, 2020, against the remote authentication of such records.
“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,” the advisory stated.
The clarification came amid differences in practice across healthcare establishments, which the commission said, created uncertainty around the remote review and authentication of medical records, professional accountability, and the security and integrity of electronic records.
The NMC clarification intended to promote uniform implementation of the existing legal framework, remove ambiguity and facilitate the responsible adoption of digital healthcare technologies.
The advisory clarified that remote authentication did not mean a doctor could sign a medical report without reviewing the relevant clinical information.
Before authenticating a report, the registered medical practitioner (RMP) must review the relevant clinical information, records, investigations and other material reasonably necessary to form a professional opinion. The doctor must also exercise independent professional judgement to determine whether the report or other clinical document is appropriate for authentication.
“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,” the advisory stated.
It meant that while a doctor need not necessarily be physically present at the healthcare establishment to authenticate an electronic report, the decision must still be based on an adequate review of the clinical material.
Using a digital or electronic signature also did not reduce the doctor’s professional responsibilities.
“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, legal responsibility of the RMP authorising such report,” the NMC said.
The advisory further stated that authentication could not be used to bypass or replace any examination, verification or professional review required under applicable law or professional standards.
The NMC has also outlined safeguards for healthcare establishments that use electronic systems to store and authenticate medical records.
Hospitals and other establishments must maintain electronic records with appropriate security measures, audit trails, authentication logs and date and time stamps. These safeguards preserve the integrity, confidentiality, and traceability of electronically authenticated records.
The advisory required establishments to retain authenticated medical records and related authentication and audit logs for the period prescribed under applicable law. They must also comply with requirements relating to data protection, privacy, information security and cybersecurity, including the processing, storage, transmission and access of personal health information.
The commission separately addressed remote authentication by doctors working with healthcare establishments.
An RMP authorised to practise under the NMC Act may remotely authenticate reports generated by an establishment with which the doctor is appointed, empanelled, contracted or otherwise professionally associated. This is subject to applicable law, a lawful professional engagement and access to the relevant clinical records.
The advisory granted doctors an independent right to practise medicine beyond their existing registration, licensing, appointment or other applicable requirements.
Foreign experts cannot independently certify Indian medical records
The NMC has also clarified the position on foreign medical experts who provide remote consultations or second opinions to Indian healthcare establishments.
The treating team may consider such opinions in accordance with applicable law. The identity, professional qualifications, registration or licence, date and nature of the consultation, and the opinion provided by the foreign expert must be documented in the patient’s medical record, to the extent applicable.
However, the advisory stated that such a consultation or opinion did not, by itself, amount to authentication or certification of an Indian medical record by the foreign expert. Nor did it grant the expert the right to practise medicine in India.
The commission has also directed that the concerned RMP must retain control of digital signatures, signature creation data, authentication credentials, access tokens, and other authentication mechanisms.
“Digital Signatures, Electronic Signatures, signature creation data, authentication credentials, access tokens or other authentication mechanisms used for 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 advisory stated.
Doctors must take reasonable care to prevent unauthorised access or use of these credentials. Any suspected compromise or unauthorised use must be promptly reported in accordance with applicable institutional and legal requirements, followed by appropriate corrective measures.
The NMC said the advisory was clarificatory in nature and intended to facilitate uniform implementation of the existing legal framework. It does not create a new statutory right or remove any requirement prescribed under applicable law.