National Council for Clinical Establishments forms sub committee for regulation on online healthcare aggregators

New Delhi, August 27, 2021:

The National Council for Clinical Establishments has recommended that the ministry of health and family welfare (MoHFW) should instruct the state governments that only registered clinical establishments may be permitted to provide online services.

The 12th meeting of the National Council, held under the chairmanship of Dr Sunil Kumar, DGHS through video conferencing on July 14, considered the issue of regulation of online health services aggregators and related service providers under Clinical Establishment Act and their standards etc. The Council noted that there was no specific provision for their regulation under the Act.

A subcommittee under Padmaja Singh, the secretary of the Council was appointed to further examine the issue of regulation of online health aggregators in detail in consultation with stake holders and law ministry, for taking appropriate action.

It also endorsed the recommendations of the subcommittee for drafting standards for collection centre, including that the public has to be made aware of illegal online health aggregators, need to frame IT/digital laws/rules to regulate them by the ministry of electronics and IT. Ministry of health and family may take it up with them and also consult ministry of law and justice in this regard, it said.

The online Lab service aggregators and service providers should have a registration number and provide information regarding the lab where the samples are being sent for testing.

While the Union ministry of health and family welfare has written a letter related to these recommendations to all States and Union Territories (UTs), the States and UTs are required to take necessary steps to regulate them, it added.

“It was recommended that all online service providers should have a linkage with the registered clinical establishments. Thus only a registered clinical establishment may be permitted to provide online services. MoHFW may issue necessary instructions to States/UTs in this regard,” said the minutes of the Council meeting, published on August 23, 2021.

The instructions by MoHFW may be enforced by the District Registering Authority at the district level and the State Council for clinical establishments at State level.

The Council also approved the draft of minimum standards for collection centres, regarding inclusion of PhD genetics and PhD scientists in the minimum standards for medical diagnostic laboratories.

According to an amended Gazette Notification in respect of human resource requirements for these laboratories, which includes provision of MSc and MSc PhD with specified qualification and experience, they are permitted to conduct the tests, generate and sign test reports as authorised signatory for the specified types of tests of their domain area in the specified category of laboratory, without recording any opinion or interpretation of the test results.

All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. PharmaBiz