Overview of  Relevant Legislations in the Medical Field

The Digital Personal Data Protection Act, 2023 has received the assent of the President of India but is yet to be notified. There is an emphasis on a more robust consent management system in all areas where digital personal data is involved. The Act envisages onerous responsibilities on those collecting data (Data Fiduciaries) and penalties for non-compliance that go up to Rs. 250 crores. There are also certain responsibilities on those providing the data (Data Principals) such as providing accurate information. Further, the Ministry of Consumer affairs has released draft guidelines to prevent platforms from engaging in ‘dark patterns’ or deceptive tactics to induce consumers to engage in certain behaviors. We are in the process of reviewing and standardizing consent forms, processes, data protection systems and privacy policies on online platforms, across the Apollo ecosystem.

The Assisted Reproductive Technology (Regulation) Act and the Surrogacy Act, both enacted in December 2021, were officially implemented in June 2022 with the release of corresponding rules. According to these laws, any clinic or bank providing services related to ART or surrogacy should be registered with the relevant Assisted Reproductive Technology and Surrogacy Authority. Further, both Acts place stringent regulations on Assisted Reproductive Technology and Surrogacy including a ban on commercial surrogacy and trading in human embryos or gametes, the requirement of obtaining various certificates/approvals from different regulatory authorities and restricting who can avail of these services based on gender, marital status, and age.

On behalf of Apollo, we had filed a Trademark Infringement Suit against a Bihar Hospital from using “New Appolo Hospital” before the Madras High Court. On 22nd November 2023, granting relief to the Apollo Group, the Court has passed an order observing that “Apollo” is a Well-Known Mark in the healthcare and pharma industry and that the name Apollo has to be given the “highest level of protection”. It granted an order of permanent injunction preventing the Bihar hospital from using the name. This is a landmark judgement and will allow Apollo to protect its brand in a much more effective manner.

The Ministry of Home and Family Welfare, in mid-2020, launched a Government Initiative and rolled out a free-of-cost telemedicine service that connects patients to empanelled doctors named ‘e-Sanjeevani’. This is a part of the Government’s larger ‘India Stack’ program. Surprisingly, on the e-Sanjeevani app, doctors simply need to upload copies/images of their signatures, when various legislations call for stricter norms relating to doctors’ electronic signatures on prescriptions. We have recommended that Apollo 247 follows the practice of the signatures of doctors being linked to an Aadhar based E-KYC service, which is the norm among most companies that deliver online services. This is a placeholder until there is more clarity on the mandatory requirements from the authorities.

Post the tragic murder of Dr Vandana Das, a young doctor, by a patient at a government hospital in Kerala’s Kollam district, Congress MP Shashi Tharoor has introduced a private bill in the Lok Sabha that aims to protect healthcare workers and medical institutions against violence. The Healthcare Personnel and Healthcare Institutions (Prohibition of Violence and Damage to Property) Bill, 2023. This is a much needed legislation since doctors continue to face the ire and threats of violence from patients, their attenders and their family causing insecurity and jeopardising patient care. The Indian Medical Association estimates that 75% of doctors face verbal and physical abuse during their service, and such cases are often underreported.

The National Medical Council has issued the “Registration of Medical Practitioners and License to Practice Medicine Regulations, 2023” under which the National Medical Register (“NMR”) is being set up to replace the existing Indian Medical Register which was maintained by the erstwhile Medical Council of India. The NMR, overseen by the Ethics & Medical Registration Board, will consolidate information on medical practitioners, including registration details and qualifications. The regulations outline the licensing process, with the issuance of a Unique Identification Number (UIN) by the Ethics & Medical Registration Board. 

The National Medical Council also issued the Registered Practitioner (Professional Conduct) Regulations, 2023 which have since been abated. This is because they drew particular ire from the healthcare industry for their de facto ban on prescribing non-generic drugs among other major issues. Though the guidelines have been abated, the Telemedicine Practice Guidelines, 2020 which they had incorporated, are still in place. The Telemedicine Practice Guidelines make specific rules on marketing, prescriptions, and consultation by doctors through Telemedicine Platforms.

The Accessibility Standard for Healthcare are a set of guidelines specifying standards for ensuring barrier-free access to healthcare facilities for persons with disabilities. The standards are applicable to public and private hospitals, nursing homes, private clinics, and public health centres. The Government has specifically made rules with respect to three categories: i.) Outdoor Patient and Emergency Department, ii.) Indoor Patient Department and iii.) Medical Equipment and Furniture.