Is Teleradiology & Telepathology in India Legal – Stirring a Hornet's Nest!!

By - Prof K. GANAPATHY

Several media reports have led to controversial interpretations, raising concerns among ethical telehealth practitioners. Perhaps overzealous journalists use the well-known "man bites dog" technique to increase eyeballing!

In Dec 2024, Dr. Rohit Jain, an RTI Activist, filed an RTI (Right to Information) application enquiring if the Telemedicine Practice Guidelines (TPG) 2020 allows an RMP to sign Pathology and Radiology lab reports via remote authentication without physical presence and supervision.

On Jan 3rd, 2025, the Ethics Committee of the National Medical Commission is said to have opined that "-- signing a lab report without physical presence is not allowed, under the law" on the grounds that the TPG does not allow remote authentication of pathology and radiology reports. However, nowhere in the TPG is it explicitly and unambiguously stated that remote reporting cannot or should not be done." It is universally acknowledged that the "law is an ass". The same rules and regulations are interpreted differently by different people at different times. There are hundreds of instances where an overruled ruling has itself been overruled! Even the first "test case" is not always a precedent.

It is equally well known that "the devil lies in its detail." Healthcare is never black or white. It is always various shades of grey. The regulators need to understand that healthcare is always contextual and dynamic, not static. Formulation, implementation and enforcement of strict, but at the same time flexible, regulations is what is required. One rotten apple does not represent the whole basket.

Peer-reviewed articles in high-impact, indexed journals have testified with incontrovertible scientific data, the reliability of remote digital histopathology, remote clinical pathology, and teleradiology. Over the last three decades, enough pilots and Proof of Concept validation studies have been carried out. These have stood the test of time. Today, these disciplines are center stage, part of the healthcare armamentarium.

Telepathology

Telemicroscopy technologies started as early as 1960. Virtual microscopy has been marketed for the last 25 years. Telepathology is the practice of diagnostic histopathology performed at a distance, with images viewed on a video monitor rather than directly through the (light) microscope. Telepathology in India was first reported by Desai et al. in 2004 using static telepathology consultation between Tata Memorial Hospital Mumbai and a rural cancer hospital in Barshi, Maharashtra. From infancy, telepathology has become an adolescent.

Many papers from India have shared individual experiences. Areas covered include specific applications, practices, benefits, limitations, regulatory issues, current advances, and a perspective on the current status of telepathology in India, with global literature reviews. The Digital Pathology Committee of the Royal College of Pathologists has published detailed guidance for remote reporting of digital pathology slides. The College of American Pathologists has done likewise.

In India, the digital pathology market is expected to grow from $31.6 million in 2023 to $62.4 million by 2030. In addition to telehistopathology, remote monitoring of clinical pathology and biochemistry laboratories is being done. Periodic, strict, remote quality control of laboratories in PHC's by NABH/NABL/ JCI accredited corporate hospitals has been in vogue in India for several years.

Today reviewing, reporting and signing radiology and pathology reports from a location different from where the image was acquired or the specimen obtained is not uncommon. Many laboratories and diagnostic centers use cloud-based software allowing doctors to review and authenticate reports from remote locations.

There are possibly 500+ professional medical/ healthcare societies in India with domain experts as members, each focusing on a particular area. One would expect the NMC to be future-ready and include Digital Health with Teleradiology, telepathology, teleopthalmology, etc., in the medical curriculum at UG and PG level and find methods to ensure that the technology is not misused. Appropriate sub-committees involving these societies, need to be constituted to understand the Big Picture, from a global perspective.

A specific framework for each discipline is required. One size does not fit all. Workshops and training sessions need to be conducted periodically by individual professional societies where domain experts in telehealth, technology, law, and ethics with practical hands-on experience are the faculty. Collaboration between different professional societies will help identify common challenges and share best practices, resulting in consensus-building. Continuous dissemination of knowledge alone will raise awareness and promote adherence.

X rays taken in rural areas are reported every day by radiologists in corporate hospitals located in urban India. This has been in existence for several years and tens of thousands of patients are benefitting. There is also an acute shortage of trained, experienced histo pathologists in various disciplines. Digital Pathology is the only way to reach the unreached. Today, distance is meaningless. Geography has become History.

Teleradiology

The teleradiology market in India is expected to grow to USD 2.43 billion by 2030. The shortage of radiologists is more common in remote areas. Though there is no specific provision giving it a legally valid status, there is no law in India that makes teleradiology illegal. 20,000 radiologists cater to 1.4 billion people. In a yet-to-be-published paper on Teleradiology Utilization Patterns in India (reviewed by the author), 74% of 309 radiologists (constituting 3% of all radiologists in India) practiced teleradiology. This speaks for itself.

To interpret incomplete Covid centric guidelines issued 5 years ago ( equivalent of Jurassic Park in the Digital health era in 2030 ) and paying undue importance to a few cases of blatant misuse ( In 2018 scanned signatures of a pathologist , with an MD pathology degree, were used to certify lab reports prepared by technicians from 200 different laboratories . The Maharashtra Medical Council opined that personal supervision of all these laboratories, would have been physically impossible. Appropriate corrective action was taken ) is equivalent to shooting the messenger.

We do hope that the NMC will not take a "forward step" in a backward direction. The NMC should – irrespective of what is mentioned or not mentioned in the TPG March 2020- guidelines and the subsequent 2.0 version, unambiguously and clearly state whether the hundreds of Teleradiology practitioners interpreting thousands of radiology images every day originating from rural, suburban, and urban India and outside India are violating NMC rules. Ideally, specific dos and don'ts should be notified after a detailed discussion with all stakeholders in the ever-growing ecosystem. A very narrow perspective can even question the legality of thousands of remote fundus examinations taking place every day.

Tele Ophthalmology Society of India – beware !!!” after all you are also signing a report without physical presence!!

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[Disclaimer: This is an authored article; DHN is not liable for the claims made in the same.]