FICCI launches self-regulatory code of conduct for e-diagnostics sector

Self-regulatory code of conduct for e-diagnostics is prepared after several rounds of industry consultations by FICCI’s e-Pharmacy working Group and aims to ensure adherence to the highest professional standards while delivering quality e-diagnostic services in a safe and compliant manner

The Federation of Indian Chambers of Commerce and Industry (FICCI) announced the launch of self-regulatory code of conduct for e-diagnostics in India. The code of conduct was launched in the presence of Manmeet K Nanda, Joint Secretary, Department for Promotion of Industry and Internal Trade, Government of India. The virtual event was also attended by representatives of health-tech companies, start-ups, non-profits, public -policy scholars, and media professionals.

Self-regulatory code of conduct for e-diagnostics is prepared after several rounds of industry consultations by FICCI’s e-Pharmacy working Group and aims to ensure adherence to the highest professional standards while delivering quality e-diagnostic services in a safe and compliant manner.

Some of the key components of the code of conduct includes: 

Responsibilities of the technology platform listing medical laboratories: Members shall provide details of the laboratories on behalf of which they are listing services and various test details to support informed decision making by the consumer. It also covers procedure for evaluation and selection criteria before listing laboratories

Requirements for safe sample collection and transportation: In addition to adherence to all exiting norms of safe sample collection and transportation, members shall put in place a regular training program for phlebotomists, ensure traceability of samples, and provisions to handle urgent requests

Requirements for clinical sample processing & reporting: Members shall ensure that a physical medical laboratory processes the sample within the stipulated time frame and generates the report. In addition to the standards of reporting, the report shall mention the identification of the laboratory and requester, and date and time of sample collection, sample receipt, report generation

Requirements for report delivery to consumer: Reports of the user shall be provided in a secured manner within the committed time frame and members shall put systems in place to monitor TAT and act on any breach

Customer grievances: Members must ensure that there is a proper mechanism in place to address any queries or grievances the end user may have. Members should also be registered with the National Consumer helpline

Adherence to applicable regulatory requirements and technical specifications: Members shall adhere to all regulatory norms, standards, and guidelines applicable in their respective State(s) of operations, process the data as per the applicable laws, and meet required technical specifications of the equipment used

Public health initiatives of Government of India: Members shall support government’s various public health initiatives coming into effect from time to time.

Speaking on occasion, Nanda congratulated the industry for launching the self-regulatory code of conduct for e-diagnostics in India. She further invited the industry for input to address any compliance issues with respect to ease of doing business.

“Industry members can sit with the FICCI and identify specific issues they face in terms of compliance and how these could be simplified. We will be happy to take in your input in this regard”, she added.