RAPID GROWTH OF E-DIAGNOSTIC INDUSTRY NECESSITATED THE CREATION OFA SELF-REGULATORY CODE OFCONDUCT

DIAGNOSTICS

Rapid growth of e-diagnostic industrynecessitated the creation of a self-regulatorycode of conduct

On 6th May 2022,FICCI launched the self-regulatory code of conduct for the e-diagnostics sector.Ritu Gupta,COO,Genes2Me explains if this will work to protect consumer/patient interests

In recent times, India has seen consolidation and strengthening of the healthcare network. With government initiatives like Ayushman Bharat Digital Mission (ABDM) and 'Atmanirbhar Bharat Abhiyaan,' encompassing the vision of Digital India, the diagnostic sectors have rapidly expanded and flourished. There has been active participation in driving the e-diagnostic sector by all concerned stakeholders-government, startups, and national diagnostic companies.

E-diagnostics is a digital diagnostic company that uses a variety of technologies to acquire, serve, and retain customers. Unlike traditional diagnostic facilities, e-diagnostics companies do not have dedicated collection centers and instead rely on a large number of phlebotomists to collect samples, which saves them a lot of money.

The COVID-19 pandemic and increased demand for home-based sample collection have boosted the category significantly in recent years.

The rapid growth of the ediagnostic industry necessitated the creation of a selfregulatory code of conduct. The FICCI's e-pharmacy working group developed the code of conduct for e-diagnostics after multiple rounds of industry discussions. It aims to ensure adherence to the highest professional standards while delivering excellent e-diagnostic services till the last mile in a safe and compliant way.

This voluntary code of conduct is an industry-led effort to conform to the highest standards of excellence and provide adequate safeguards to ensure that patients' health and safety are not endangered.

Unlike traditional diagnostic facilities,e-diagnostics companies do not have dedicated collection centers and instead rely on a large number of phlebotomists to collect samples,which saves them a lot of money

Need for code of conduct

According to a recent survey, India had 5,295 healthtech startups at the end of 2020, and the number has risen dramatically since then. Between 2023 and 2027, India's diagnostic labs market is predicted to increase at a CAGR of 11.65 per cent to $25.66 billion.

The key problems for lastmile access to the diagnostic sector include accessibility, price, and lack of awareness. Adopting technology, particularly the internet, into the healthcare system could successfully eliminate these constraints.

In recent years, e-diagnostic has emerged as an important conduit for providing last-mile access to laboratories. This will mostly benefit individuals with chronic conditions, the elderly, and sick patients who are unable to travel to get their tests performed.

New tech-enabled platforms are helping improve access to high-quality healthcare services, such as diagnostic services, by bringing services to the patient's door, expanding the patientcantered approach, and athome care. They also provide tracking and traceability of the services that are supposed to be provided through their platforms.

The e-diagnostic model provides sample tracking and traceability, addressing the issue of counterfeit reports, eliminating the need of infrastructure in rural areas, and making use of limited human resources, as well as providing value-added services for consumer empowerment in healthcare, all of which are well aligned with the government's Digital India initiative, which reshapes the country into a digitally empowered society.

Benefits of the code of conduct

The e-diagnostic sector has taken a positive step by adhering to the FICCI self-regulatory code of conduct to assure service consistency and quality maintenance. This is a crucial step because if the industry self-regulates, it would be able to accomplish both structured growth and consumer protection.

The code of conduct highlights the obligations of technology platforms that list medical laboratories. All member firms will have to ensure that labs are listed in a transparent manner on their platforms. They will also be required to disclose thorough information about laboratories and test results in order to assist clients in making "informed decisions." The standard code of conduct will help deliver quality e-diagnostic services to the last mile safely and promptly.

The code also instructs the platforms to create a system for selecting and assessing documented laboratories. In addition, to maintain service standardisation, the members must specify all standard operating procedures (SOPs) surrounding factors such as sample collection, transportation, and storage.

The code of conduct attempts to guarantee that the space is self-regulated and that services are uniform across the industry. Furthermore, this will help in standardising quality control across the board for diagnostics companies and startups in the country.

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