Guidelines for ICU Admission and Discharge Criteria
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW MOHFW Guidelines on Intensive Care Unit Admission and Discharge Criteria The Ministry of Home and Family Welfare (MoHFW) recently released guidelines on “Intensive Care Unit Admission and Discharge Criteria, 2023”. The guidelines, which are based on the consensus of 24 medical experts from all across India, deal with when to admit and discharge a patient, to and from, the ICU. Notably, they touch upon the rights of patients with living wills/advanced directives against the usage of ICUs for their treatment, prioritization of patients during a resource crunch, essential qualifications of an intensivist, and the medical criteria for admission and discharge. It is important to note that the guidelines do not seem to contain any consequences for non-compliance. However, the publication of them is a welcome move considering that in the area of critical care, in a country with a population like India, healthcare providers would be required to prioritize certain patients over others. Further, the provision of mandatory medical conditions and stabilizations stipulated in the guidelines will provide medical personnel with a roadmap to provide legally compliant medical treatment and in turn protect their medical and legal interests. The Guidelines have been attached hereunder. INTENSIVE CARE UNIT ADMISSION AND DISCHARGE CRITERIA This document was compiled by the following Doctors with Expertise in Critical Care Medicine working in different levels of Hospital and Intensive Care Units (ICU) across the country. Experts : Dr. Sheila Nainan Myatra, Tata Memorial Hospital, Mumbai Dr. RK Mani, Yashoda Superspeciality Hospital, Kaushambi, Ghaziabad Dr. Anjan Trikha, AllMS, New Delhi Dr. Ashish Bhalla, PGIMER Chandigarh Dr. Asim Kumar Kundu, IPGMER, Kolkata Dr. Banani Poddar, SGPGI, Lucknow Dr. Dhruva Chaudhary, PGIMS, Rohtak Dr. Dina Shah, Fortis Hospital, Noida Dr. E Lenin Babu, JIPMER Puducherry Dr. HC Sachdeva, Safdarjung Hospital, New Delhi Dr. Indu A Chadha, BJMC Ahmedabad, Gujarat Dr. JV Peter, CMC Vellore Dr. JV Divatia, Tata Memorial Hospital, Mumbai Dr. Kanwalpreet Sodhi, Deep Hospital, Ludhiana, Punjab Dr. Lokesh Kashyap, AllMS, New Delhi Dr. Niteen Karnik, LTMGH (Sion Hospital), Mumbai Dr. Padmaja Durga, Nizam’s Institute of Medical Sciences, Hyderabad Dr. Pradip Bhattacharya, RIMS, Ranchi Dr. Prashant Nasa, NMC Specialty Hospital, Dubai Dr. Virendra K Arya, Max Rady College of Medicine, University of Manitoba, SBGH, Winnipeg, MB, Canada Dr. Srinivas Samavedam, Ramdev Rao Hospital, Hyderabad Dr. Subhash Todi, AMRI, Kolkata Dr. Swagata Tripathy, AllMS Bhubaneshwar 24. Dr. Krishan Kumar, CMO(SAG), Dte.GHS – Member Secretary What is an Intensive Care Unit (ICU) and who is an Intensivist Intensive Care Unit (ICU)1 The terms Critical Care /Intensive Care/Intensive Therapy Unit are synonymous. It is a designated, specialized area for multidisciplinary, focused management of patients who have life-threatening, partially, or completely reversible organ(s) dysfunction. Such treatment requires continuous and intensive observation and interventions by a multi professional team of appropriately trained healthcare workers including doctors, nurses and other support staff with equipment and paraphernalia necessary for sustaining life until recovery. Intensivist or Critical Care specialist2,3 A specialist who has specific training, certification and experience in managing critically ill patients in an ICU. The Intensivist should have a postgraduate qualification in Internal Medicine, Anaesthesia, Pulmonary Medicine, Emergency Medicine or General Surgery with either of the following: An additional qualification in Intensive Care such as DM Critical Care/Pulmonary Critical Care, DNB/FNB Critical Care (National Board of Examinations), Certificate Courses in Critical Care of the ISCCM (IDCCM and IFCCM), Post-Doctoral Fellowship inCritical Care (PDCC/Fellowship) from an NMC recognised University, or equivalent qualifications from abroad such as the American Board Certification, Australian or New Zealand Fellowship (FANZCA or FFICANZCA), UK (CCT dual recognition), or equivalent from Canada b) At least one-year training in a reputed ICU abroad. A few candidates of the ISCCM Certificate Course (CTCCM) who have been certified with a 3- year training programme in Intensive Care after M.B.B.S. are also recognised as Intensivists. In addition, persons so qualified or trained must have at least two-years’ experience in ICU (at least 50% time spent in the ICU). In case of doctors not having either of the above mentioned qualifications or training, they should have extensive experience in Intensive Care in India after M.B.B.S., quantified as at least three years’ experience in ICU (at least 50% time spent in the ICU). EXPERT CONSENSUS STATEMENTS TheExpert consensus statementshave been made using the Delphi methodology to generate consensus. The Steering Group for Delphi process was SNM, RKM and PN who conducted the Delphi surveys using Google forms, prepared the Delphi statements and the reports. The Steering Group did not vote in Delphi surveys. The rest of the Experts voted anonymously over three rounds. Consensus was defined as achieved for an option when voted by 70% or more of the Experts. Stability was checked for all responses. The final statements were drafted from the MCQ responses that achieved consensus and stability. 1.Criteria for admitting a patient to ICU should be based on organ failure and need for organ support or in anticipation of deterioration in the medical condition. 2. ICU Admission Criteria: Altered level of consciousness of recent onset Hemodynamic instability (e.g., clinical features of shock, arrythmias) Need for respiratory support (e.g. escalating oxygen requirement, de–novo respiratory failure requiring non-invasive ventilation, invasive mechanical ventilation, etc.) Patients with severe acute (or acute–on–chronic) illness requiring intensive monitoring and/or organ support Any medical condition or disease with anticipation of deterioration Patients who have experienced any major intraoperative complication (e.g. cardiovascular or respiratory instability) Patients who have undergone major surgery, (e.g. thoracic, thoraco–abdominal, upper abdominal operations, trauma who require intensive monitoring or at a high risk of developing postoperative complications). 3. The following Critically Ill Patients should not be admitted to ICU: Patient’s or next–of–kin informed refusal to be admitted in ICU Any disease with a treatment limitation plan Anyone with a living will or advanced directive against ICU care Terminally ill patients with a medical judgement of futility Low priority criteria in case of pandemic or disaster situation where there
New Criminal Laws- Doctors Protest & Advisory on Spine Surgery
NEW CRIMINAL LAWS – DOCTORS PROTEST The Tamil Nadu Government Doctors’ Association (TNGDA) has made a decision to refrain from performing elective procedures and surgeries until protective clauses under relevant sections are introduced in the Bharatiya Nyaya Sanhita, 2023 (“BNS Act”). The decision came in response to the request made by government doctors in Tamil Nadu to the Chief Minister, M K Stalin, to intervene and ensure that protective clauses are added to the latest act that replaced the Indian Penal Code (IPC). The President of TNGDA, Dr. Senthil in his letter to the Chief Minister referred to Section 106 of BNS Act 2023 that empowered police officers to register an FIR for every instance of negligence and not only those that amounted to criminal negligence. Further, sections 88, 89 and 90 were also pointed out wherein medical practitioners can be barred by the police from performing medical termination of pregnancy in 95% of cases as specified in the Medical Termination of Pregnancy (MTP) Act 1971. Further, if doctors follow these sections of the BNS Act, only 5% of the MTP cases can be taken up. Other indications for terminating pregnancies such as foetal anomalies, rape victims, contraceptive failure and all other indications where termination may be needed beyond 16 weeks of pregnancy, cannot be taken up. With the BNS Act having come into effect on 1st July 2024, doctors across the country expressed dissatisfaction with specific sections, especially Section 106 of the BNS Act which replaced Section 304A, which has made it mandatory for registered medical practitioners to serve a jail term if they are found guilty of negligence not amounting to culpable homicide. The problem in the section, as pointed out by the President of TNGDA, is how imprisonment has become mandatory while earlier under the IPC, it was either imprisonment for up to 2 years or a fine. He also pointed out that the new BNS Act does not provide a provision for a distinction between negligence that could be considered criminal negligence and otherwise. He explained that this has made doctors anxious and hesitant as they can be booked under the BNS Act Act even for cases of a frivolous nature. WHO CAN PERFORM SPINE SURGERY? Spine surgeries are required for spinal deformities, spinal inspections, trauma, spine tumours, stenosis and herniated disks. These surgeries are either performed in an open (traditional) spine surgery procedure or by using minimally invasive techniques involving a smaller incision and the insertion of a tube. The National Medical Commission has provided much-required clarity on the question of “Who can perform spine surgery?” On 15.07.2024, the Ethics & Medical Registration Board of the National Medical Commission issued a notification on the ‘Eligibility of Orthopaedic surgeons for performing Spine Surgery.’ The notification was issued in response to the representation of the Association of Spine Surgeons in India. A meeting was held by the Postgraduate Medical Education Board (PMEB) on 24/11/2023 and PMEB has stated that apart from spine surgeons, both orthopaedic and neurosurgeons are competent to perform spine surgeries.
Madras High Court Grants Interim Relief to Doctors Over Vehicle Stickers Ban
Madras High Court Grants Interim Relief to Doctors Over Vehicle Stickers Ban In a recent development, the Hon’ble Madras High Court has granted interim relief to doctors and directed the police to refrain from initiating action against medical professionals displaying professional logos or stickers on their private vehicles. The plea was in response to a recent circular released by Greater Chennai Traffic Police (GCTP) banning the use of stickers indicating professions such as Doctors, Lawyers, Press, and Police, from 2 May 2024, stating that such stickers are used as a tool of misuse to gain immunity. The intervention of the Hon’ble High Court was followed by a plea filed by the Doctors Welfare Association which sought exemption from police action against doctors for placing professional identifiers on their private vehicle. The plea argued that the role of such professional stickers is to navigate through traffic and checks in case of emergency cases seamlessly, without delay, and not to gain immunity. The National Medical Commission (NMC) and Tamil Nadu Medical Council (TNMC) were suggested to provide authorised vehicle stickers to medical professionals, similar to the Bar Council’s practice for advocates. The High Court observed that genuine medical professionals should not be penalised considering the critical nature of their work where timely response to medical emergencies are of utmost importance. Further, the Hon’ble High Court noted that authorised stickers are to be properly affixed either in the front or rear sides of the vehicles and not on the number plates that would help distinguish genuine medical practitioners from those who are misusing such identifiers. However, the Court stated that the police should stop and check suspicious vehicles to prevent sticker abuse. The case has been scheduled for final hearing on June 14, 2024. Meanwhile, the Hon’ble High Court has barred the police from initiating action against medical professionals displaying professional stickers until NMC and TNMC submit their response and potentially establish a policy for issuing authorised stickers to doctors, as suggested by the Court. Second Opinion in Medical Dilemmas In Laxmikant Vittalrao Pandav & Ors v/s Akar Hospital & Ors, the State Commission dismissed a case against the hospital and doctors, affirming that second opinions in medical dilemmas is a commendable practice that benefits patients. The patient was under antenatal care at the hospital for two months of her pregnancy and a final ultrasound revealed severe oligohydramnios with the umbilical cord around the neck and cephalopelvic disproportion. An elective lower segment caesarean section (LSCS) was successfully performed five days before the expected delivery date. Post bleeding was later detected at the surgical site that evening. The medical team in response conducted an exploratory laparotomy and sought a second opinion from a senior gynaecologist, physician and anaesthetist. After the laparotomy, the patient was diagnosed with disseminated intravascular coagulation and was placed on a ventilator. Following the events, the patient was transferred to another hospital 100 kilometers away where she unfortunately passed away due to interstitial pneumonia with pulmonary oedema and acute tubular necrosis post-LSCS. The patient’s family alleged that the laparotomy was performed without consent and necessary investigations and claimed unauthorised involvement of other doctors. The hospital and doctors stated that based on the discussions and second opinions, a re-exploratory laparotomy was deemed necessary and the patient’s attendants were kept informed throughout. Upon reviewing the medical records, the Court noted that the patient received timely and thorough care during her postoperative period. It was further observed that re-exploration in the given case was urgent and that the surgery was performed after obtaining informed consent. It was concluded by the State Commission that involvement of additional doctors was a collective and authorised effort and not unauthorised as alleged. Further, the Commission held that no consent of the patient/attendants is required for such consultations inter-se amongst doctors and emphasised that consulting other doctors in critical situations is a prudent practice and such collaborative efforts aid in providing the best possible care to the patient.
Sapien Biosciences’ Perspective On Navigating India’s Regulatory Framework In The Realm Of Biobanking.
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family, As Group Legal Advisor for the Apollo Group, BADSHALEGAL is pleased to announce the launch of its ‘KNOW YOUR LAW’ Series with periodical updates, Insights and advisories on laws relating to Healthcare, Life Sciences, Technology and related topics APOLLO has extensively incorporated Artificial Intelligence (AI) & Machine Learning (ML) in clinical areas, advanced precision medicine, and data moving to the cloud with data sharing becoming the norm. It is hence crucial that the framework for legal compliance in the Group is also future-ready. The European Union is in the process of finalising a comprehensive regulation on AI, and is a forerunner in regulating this emerging technology, but the present regulatory regime in India has not kept pace with the proliferation of technology in the realm of healthcare and there remains an ambiguity in several areas of applicable laws. Until it evolves, it would be wise to benchmark legal compliance against international standards. We open the Series “In Conversation” with Dr. Jugnu Jain, Co Founder & CEO, Sapien Biosciences, a JV between Apollo Hospitals & Saarum Innovations, founded in the year 2013, to create a world class bio-bank and personalised medical company. Sapien has recently digitised their repository of 10,000+ curated and annotated breast cancer samples. It has created a library of matched sets, high resolution scanned images of H&E and IHC biomarkers, for the AI-driven predictive algorithms for personalised medicine. Read on for an overview of Sapien’s perspective on navigating India’s regulatory framework in the realm of Biobanking. Look forward to your views and feedback! Sincerely, Maimoona Badsha. In Conversation with Dr. Jugnu Jain, Founder & CEO of Sapien Biosciences Q: How do you maintain Patient Privacy and Confidentiality in Sapien? A: As a biobank, Sapien is engaged in biomedical non-clinical research. The formations and operations of a biobank including the procedures to deal with biological material and data relating to it, fall under Indian Council of Medical Research (ICMR)’s ‘National Ethical Guidelines for Biomedical and Health Research Involving Human Participants’. Sapien adheres to such guidelines by obtaining relevant Ethics Committees’ approvals as well as protecting patients’ identity and privacy by appropriately coding the samples and data. Q: What are the steps taken for anonymisation and pseudonymisation of data as means of privacy protection at Sapien? A: Sapien follows pseudonymization or coding of patient data which means that the user of samples or data cannot know the identity of the patient. All patient identifiers such as hospital number (MRN, UHID, UID), lab sample or report number (LRN, LID), date of procedure, date of sample collection, name, address, contact information of patient, etc., are all removed and coded carefully to safeguard identity and privacy. Q: What are the Legal & Ethical standards applied to Procurement, Storage, and Transfer of Tissues and Cells for Non-Clinical Research Purposes? A: Samples and data at Sapien have been procured after building a solid foundation of ethical and legal compliance since Sapien is a pioneer in private biobank-ing in India. The following procedure is undertaken for the same: ➢ Significant deliberation and consensus-building were done at the start with the members of Institutional Ethics Committees (IECs), lawyers familiar with ethical and legal guidelines, scientists involved in drafting ICMR guidelines, studying international biobanking norms, and clinicians, pathologists, hospital management, etc. ➢ A 2-step process has been implemented whereby; First, procurement of remnant samples from pathology and other labs is done in bulk for biobanking with the review and approval from each participating hospital’s IEC. Second, the use of specific samples and/or data maintained in the biobank at Sapien is then again reviewed by another DHR-registered IEC (of the biobank) using a project and user-specific protocol. The probability of harm or discomfort anticipated in the research is nil or not expected for research on anonymous or non identified data/samples, as per ICMR. ➢ A Material Transfer Agreement (MTA) and /or Data Sharing Agreement (DSA) is entered into, defining the terms of the project between the biobank and the user of the samples and/or data prior to submitting a protocol to the IEC and sharing any material /data with the user. The end-user covenants that the samples and data will be used only for the specified purpose for which the IEC approval is taken. Q: What are the Rights and Entitlements in Human Tissue and Cells? A: Usually, human tissue removed as part of standard medical procedures such as blood for diagnosis or tissue during surgery as part of treatment, belongs to the patient and the hospital acts as the custodian of the sample. As per National Accreditation Board for Testing and Calibration Laboratories (‘NABL’) guidelines, the pathology blocks from which diagnosis is made in NABL-accredited pathology labs are to be stored for a minimum of 5 years, prior to 2019. Post-2019 revision of NABL guidelines, diagnostic blocks made from 2019 onwards need to be stored for 10 years. After the term is over, many hospitals do not keep the blocks due to lack of space and manpower to maintain them. The samples can be used for research purposes after completion of NABL-mandated storage period and after fulfilling the conditions as defined in ICMR guidelines for biobanking and relevant IEC approval. Another type of sample is where researchers collect fresh tissue from routine surgeries or additional blood samples with the patient’s or caregiver’s consent. The purpose of collection, terms of use, safeguards to protect patient identity and privacy, etc., are spelt out in the informed consent including that in the event that their donated samples are used for projects that lead to a commercial output the donor does not have a right to commercial benefit. If the patient /caregiver consents, then that sample is taken and biobank-ed for R&D projects. These additional, non-diagnostic samples do not fall under the 5 or 10-year NABL storage limit. Q: What are the challenges faced
Artificial Intelligence in Biomedical Research & Healthcare
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family, The Indian Council For Medical Research (ICMR) has released the Ethical Guidelines for the application of Artificial Intelligence in Biomedical Research and Healthcare, 2023 (‘Guidelines’) https://main.icmr.nic.in/content/ethical-guidelines-application-artificial intelligence-biomedical-research-and-healthcare With this, India gets its first ethics framework for the deployment of Artificial Intelligence (‘AI’) in healthcare and biomedical research. Although these Guidelines are only recommendatory/advisory in nature and are not binding, they open the doors to a larger discussion on the need for a robust regulatory regime on AI in healthcare. The Guidelines recognize the ethical challenges in the application of AI in healthcare and biomedical research and intend to put in place sufficient checks and balances to ensure that ethics is a cornerstone in the decision-making process when relying on /developing AI-driven solutions. The Guidelines also provide mechanisms for the delivery of healthcare services by applying AI techniques, therefore, covering a wide range of applications such as diagnostics and screening, therapeutics, drug discovery and development, clinical care, epidemiology and prevention of disease, behavioral and mental healthcare, health management systems using AI, medical AI software for clinic management systems, medical AI software for hospital management systems. There is emphasis on effective informed consent, data privacy, accountability and liability, and the role of Ethics Committees including an Ethics Checklist of AI for Biomedical Research and Healthcare. The Guidelines highlight ethical practices in the application of AI/ Software as a Medical Device (SaMD), regulated under the Drugs and Cosmetics Act, 1940. SaMD is a medical device if it is used for diagnosis, prevention or monitoring of any disorder or disease, is part of or used in conjunction with a device or is capable of or assists in the investigation of any physiological process. Such AI/SaMD must comply with several Indian regulations and global standards applicable to medical devices. However, while the Guidelines touch on the ethical aspects, comprehensive laws to cover the complexities of the real-time application of such AI/SaMD in the healthcare industry are yet to be formulated. Look forward to your views and feedback! Sincerely, Maimoona Badsha Group Legal Advisor, Apollo Group
E-Prescriptions & Legal Requirement of a Digital Signature.
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family, The Telemedicine Practice Guidelines, 2020, allow an RMP to prescribe non schedule drugs by a photo, scan, digital copy of a signed prescription or E-Prescription to a patient via email or any messaging platform. However, The Information Technology Act, 2000 mandates that if information is digitally transmitted and requires authentication by a signature then a “digital signature” should be affixed on such document. An Act will override any Guidelines and in this case opens the doors on a discussion whether every RMP has to have a digital signature to be able to prescribe a digitally transmitted prescription. Read on to understand the interplay of the laws on the subject. Look forward to your views and feedback! Sincerely Maimoona Badsha E-PRESCRIPTIONS & LEGAL REQUIREMENT OF A DIGITAL SIGNATURE The COVID-19 virus outbreak affected every facet of our lives, and the highest impact was felt on the health and delivery of healthcare services. ‘Telemedicine services’, albeit in existence for several decades, became an important component of medical practice. With the passing of the Telemedicine Guidelines, 2020 a legal framework for the remote monitoring of patients was put in place. An issue that has arisen for consideration is: What is the permissible mode of an E-prescription and specifically the legal form of a physician’s signature on an electronically delivered document such as this? Relevant Provisions of Law A.The Electronic Health Record Standards, 2016: These Standards issued by the Ministry of Health and Family Welfare specify that the Pharmacy Practice Regulations, 2015 are the standard for ‘E-prescriptions’. B.The Pharmacy Practice Regulations, 2015: What is a Prescription? A ‘prescription’ is defined to mean a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners such as a Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated drug to a patient. Contents of a Prescription? The contents of the Prescription include inter alia the details of the prescriber, patient, date, medication, directions, and prescriber’s signature. Therefore, the Regulations acknowledge the electronic directions given by a prescriber to a patient and mandate the signature of the prescriber for a valid prescription. C.Telemedicine Practice Guidelines, 2020 What is the Mode of Prescription? RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. D.The Information Technology Act, 2000 What Are the Mandatory Requirements of a “Signature” under the Act? The Act provides that information shall be authenticated by: (i)affixing the signature; (ii)be signed; (iii)bear the signature then, notwithstanding anything contained in such law, such requirement shall be deemed to be satisfied by means of a digital signature affixed on such document. Therefore, although the Telemedicine Guidelines do not mandate a Digital Signature, the IT Act, 2000 mandates that all information provided in a digital format is to be authenticated by a digital signature. The latter is the substantive law on this subject and cannot be overridden by the Guidelines. Conclusion The legal position on the subject matter as it stands today is to affix a digital signature on an e-prescription so as to accord requisite authenticity and legitimacy to the same.
Online Sale of Medicines
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family, Online sale of medicines continue to hold our attention since they are being closely monitored by the government and there is a proposal to introduce new regulations to control the modalities of such sale. In a welcome move, as part of the G20 health working group meeting, online pharmacies such as PharmEasy, Tata 1mg, Flipkart and Amazon India, held a discussion with the health ministry officials. They were asked to make a presentation to the government on the benefits of online sales of drugs, which will aid the government in formulating the regulations. The possibility of an absolute ban on online sales has been ruled out by the health ministry, which is a huge relief. What is also comforting is that the government is open to inputs from the industry to aid the decision making process. A dialogue of this kind should hopefully ensure that the regulatory framework the government proposes will measure up to ground reality or virtual reality, in this case! To know more on this subject: http://bwhealthcareworld.businessworld.in/article/E-pharmacies-Hold Discussions-With-Govt-Consult-New-Regulation-Policy-On-Online-Sale Of-Meds/21-04-2023-473700 In other news, while the world is moving closer to digitization and reliance on AI, the legal community has protested against a “robot” lawyer, which was all set to represent a client in an US courtroom! The State Bar threatened the U.S based manufacturer with prison time. A whole new world is ready to open up! Maimoona Badsha, Group Legal Advisor.
Overview of Relevant Legislations in the Medical Field
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family, Over the past few months there has been considerable discussion & activity in the realm of legislation that impact the healthcare industry. It has been an ongoing challenge to ensure legal compliance in the absence of comprehensive legislation for several medical related activities. Many of those issues have been addressed through significant developments in laws relating to the medical field. This issue of this BL Newsletter provides you with a brief overview of these revisions in the laws. Look forward to your views and feedback! Maimoona Badsha, Group Legal Advisor. 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.
Legal Update on End-of-Life Care
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family. At some point in time each of us has had to face the anguish of losing a loved one. How much harder it becomes when as a family member/guardian you are called upon to make end of life decisions for the patient lying incapacitated in the ICU, on life support or in a situation he/she cannot make decisions. Up until now, in such scenarios, doctors provided patients’ families with the Do Not Resuscitate (DNR) option. The defining moment is recognising futility of care and giving a patient the chance to have a dignified end. It becomes a collaborative process with doctors setting expectations and families making informed decisions on the continuum of care. In 2018, based on a Petition filed by a registered society named Common Cause, the Supreme Court recognised the right to die with dignity as a fundamental right. It also gave effect to Advanced Medical Directives (Living Will) to allow people with declining health or terminal illnesses to execute a document that will give them autonomy to make end of life care decisions. Unfortunately, the guidelines the Supreme Court put in place were virtually impossible to act on and in January 2023 they passed an order simplifying the procedure for execution of Advance Directives and provided the guidelines to give effect to a patient’s wishes in both circumstances, namely, where there are Advance Directives and where there are none. In the light of this judgment Apollo Hospitals, Chennai has taken the initiative to constitute a committee, which shall formulate and implement an effective and rational SOP for end of life care. For an overview of the legal position on this subject, please see the attachment. Sincerely Maimoona Badsha LEGAL UPDATE ON END-OF-LIFE CARE The Supreme Court in its Judgement dated March 9th,2018 in the matter of Common Cause (A Regd. Society) vs. Union of India and anr., discussed the concept of Advance Directives. “Advance Directives for health care go by various names in different countries though the objective, by and large, is the same, that is, to specify an individual’s health care decisions and to identify persons who will take those decisions for the said individual in the event he is unable to communicate his wishes to the doctor.” In an application filed by the Indian Society of Critical Care Medicine seeking clarification of the judgment reported in Common Cause (A Registered Society) v. Union of India and anr, a Constitution bench of the Supreme Court, passed an Order dated January 24th,2023 simplifying the process earlier suggested in the matter of end of life care. The Apex Court laid down principles for the execution of Advance directives and guidelines in both circumstances — where there are Advance Directives and where there are none. Valid Elements for Advanced Directive: 1)The Advance Directive can be executed only by an adult who is of a sound and healthy state of mind and in a position to communicate, relate and comprehend the purpose and consequences of executing the document. 2)It must be voluntarily executed and without any coercion or inducement or compulsion and after having full knowledge or information. 3)It should have characteristics of an informed consent given without any undue influence or constraint. 4)It shall be in writing clearly stating as to when medical treatment may be withdrawn or no specific medical treatment shall be given which will only have the effect of delaying the process of death that may otherwise cause him/her pain, anguish and suffering and further put him/her in a state of indignity. 5)It should clearly indicate the decision relating to the circumstances in which withholding or withdrawal of medical treatment can be resorted to. 6)It should be in specific terms and the instructions must be absolutely clear and unambiguous. 7)It should mention that the executor may revoke the instructions/authority at any time. 8)It should disclose that the executor has understood the consequences of executing such a document. 9)It should specify the name of a guardian or close relative who, in the event of the executor becoming incapable of taking decision at the relevant time, will be authorized to give consent to refuse or withdraw medical treatment in a manner consistent with the Advance Directive. 10)In the event that there is more than one valid Advance Directive, none of which have been revoked, the most recently signed Advance Directive will be considered as the last expression of the patient’s wishes and will be given effect to. 11)An individual may withdraw or alter the Advance Directive at any time when he/she has the capacity to do so and by following the same procedure as provided for recording of Advance Directive. Withdrawal or revocation of an Advance Directive must be in writing. 12)It will be open to the executor to revoke the document at any stage before it is acted upon and implemented. PROCEDURE FOR EXECUTING AN ADVANCE DIRECTIVE 1)The document should be signed by the executor in the presence of two attesting witnesses, preferably independent, and attested before a notary or Gazetted Officer. 2)The witnesses and the notary or Gazetted Officer shall record their satisfaction that the document has been executed voluntarily and without any coercion or inducement or compulsion and with the full understanding of all the relevant information and consequence. 3)The executor shall inform, and hand over a copy of the Advance Directive to the guardian or close relative, as well as to the family physician, if any 4)A copy shall be handed over to the competent officer of the local Government or the Municipal Corporation or Municipality or Panchayat, as the case may be. The aforesaid authorities shall nominate a competent official in that regard who shall be the custodian of the said document. 5)The executor may also choose to incorporate their Advance Directive as a part of the digital
Restrictions & Guidelines: Medical Practitioners/Institutions Advertisement of Services/Credentials
Restrictions & Guidelines: Medical Practitioners/Institutions Advertisement of Services/Credentials Uniform Code for Pharmaceutical Marketing Practices, 2024 On 12th of March, 2024, the Department of Pharmaceuticals released the “Uniform Code for Pharmaceutical Marketing Practices (“Code”). All Indian Pharmaceutical Associations are to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of this Code. The Code essentially focuses on promotional activities relating to drugs, which include “all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.” The section that applies to medical professionals is similar to the principles in the Medical Council of India, 2002 Regulations and Telemedicine Guidelines with an addition of “ Brand Reminders”, which permits distribution to medical professionals the following: Informational and education items books, calendars, diaries, journals (including e journals), dummy device models and clinical treatment guidelines for professionals used in healthcare settings value of which does not exceed Rs. 1000 per item. Such items should not have an independent commercial value for the healthcare professionals; and Free samples of drugs, which shall not be supplied to any person who is not qualified to prescribe such a product. and the monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year. There is also an exception that allows Pharmaceutical Companies to sponsor travel and hospitality to doctors if they are speakers of a CME or CPD Program. These CMEs are required to be mandatorily conducted in India. This exception did not exist in the 2002 Regulations. Medical Council of India, 2002 Regulations and TMP Guidelines MCI (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Clause 6.1.1 banned the “self-aggrandisement” of doctors and has summarised what a doctor can show of themselves in public. In clause 6.8, they have detailed a code of conduct for doctors in their relationship with the pharmaceutical and allied healthcare industry. The Telemedicine Practice Guidelines in Guideline 5 have placed a ban on doctors participating in platforms that provide ratings including reviews, advertisements and promotion of the doctors by “any means”. Any means includes the manipulation of algorithms and search engines. Consumer Protection Act, 2019 The Consumer Protection Act, 2019 (“COPRA”) which weighs heavily in the favor of consumers deals with misleading advertisements which i) falsely describes a product or service, ii) gives a false guarantee or is likely to mislead the consumers as to the nature, substance, quantity or quality of a service, iii) conveys an express or implied representation which if made by the service provider would constitute and unfair trade practice and iv.) deliberately conceals important information. It has also been recommended by the Department of Consumer Affairs that the Indian Standard (IS) 19000:2022’ should be complied with. Essentially these standards prescribe guidelines for online consumer reviews. In November 2023, news reports indicated that the same will be made mandatory and actionable under the Consumer Protection Act, 2019. Key highlights of the framework relevant to the medical industry include that the reviews on online e-commerce platforms should be published accurately, that the review information should be handled in a secure and confidential manner and the manner of collection of such a review. For example, while soliciting the review, the invitation should mention who is the person soliciting the review, the details of the product or service for which the review is sought, how the review will be used and what is the exact material that will be published. Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 The 2022 Misleading Advertisements Guidelines require advertisements to a) contain truthful and honest representation, b) not mislead consumers by exaggerating the benefits, c) not suggest the claims as universally accepted when there is significant informed view to the contrary, d) to ensure that unsubstantiated claims do not mislead consumers; and e) comply with sector specific rules and regulations. The guidelines further set regulations for bait advertisements, free claim advertisements and children targeted advertisements. They contain a complete ban on surrogate advertisements. Guidelines on Dark Patterns A dark pattern is a User Interface that is craftily designed in order to trick user in order to perform such actions. Guidelines relating to deceptive practices used by e-commerce companies were released by the Central Consumer Protection Authority on the 30th of November, 2023. The Guidelines identify 10 dark patterns which are considered as unfair trade practices under the Consumer Protection Act 2019. The dark patterns identified are false urgency, basket sneaking, confirm shaming, forced action, subscription trap, interface interference, bait and switch, drip pricing, disguised advertisement, nagging, trick question, SAAS Billing and Rogue Malware. An example provided as per the guidelines is as follows: “While giving a choice to opt, “Do you wish to opt out of receiving updates on our collection and discounts forever?” using phrases like, “Yes. I would like to receive updates” and “Not Now”, instead of the option, “Yes”. The Drugs and Magic Remedies (Objectionable Advertisements Act, 1954) One of the older legislations in this list, an amendment was proposed to this particular law in 2020. The Act places a blanket ban on the advertisement of drugs for diseases and disorders such as miscarriage, menstrual disorder, miscarriage or conception and a list of about 54 other diseases and ailments. Further, section 4, prevents false and misleading claims related to drugs and prevents doctors from taking part in the publication of such advertisements. Penalties include imprisonment with a fine and are divided on the basis of the number of convictions. The Advertising Standards Council of India Code and Guidelines Products of the Advertising Standards Council of India (ASCI), these codes and guidelines are non-binding and no legal action can be taken on this basis. However, adherence to them are considered to be good industry practice in the advertising industry and it is advisable to follow them. The ASCI Code contains four