Telemedicine in India

Telemedicine in India

The society is developing rapidly in different fields such as education, employment, IT fields which also include health and medicine. The integration of telemedicine into the healthcare system has revolutionized medical practice in India, providing greater accessibility to healthcare services across geographical boundaries. However, this growth comes with significant medico-legal challenges.

This blog explores the legal framework governing telemedicine in India, focusing on the implications of the Telemedicine Practice Guidelines 2020. It examines issues related to doctor-patient confidentiality, informed consent, liability, data protection, and the standard of care expected in telemedicine. 

Further, the blog aims to provide a comprehensive understanding of the regulatory environment, identify potential legal risks, and propose measures for mitigating them to ensure safe and legally compliant telemedicine practices. 

The definition of Telemedicine has been defined by the WHO(World Health Organization) via “The Guide to Telemedicine in Primary Health Care was developed with technical and financial assistance from UNICEF Romania under the project defines it as “Innovative tools for the improvement of local healthcare delivery capacity”, a project that has been shaped and implemented by the Centre for Health Policy and Services Foundation. as “the delivery of healthcare services using information and communication technologies for the exchange of valid information for diagnosis, treatment, and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, where distance is a critical factor”.

The “Telemedicine Practice Guidelines,” which were published by the Indian government in March 2020, are now part of Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulation, 2002.

Important facts related to the telemedicine 

Who can practice telemedicine?

Telemedicine consultations may be conducted by any Registered Medical Practitioner (RMP) who is registered with either the Indian Medical Registry or the State Medical Register. As of right now, no particular qualifications are needed. But in order to allow an RMP to practise telemedicine, the government intends to launch an online course that must be completed.

To enable all those RMPs who would want to practice telemedicine get familiar with these Guidelines as well as with the process and limitations of telemedicine practice: 

∙ An online program will be developed and made available by the Board of Governors in supersession of Medical Council of India.

∙ All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification. 

∙ In the interim period, the principles mentioned in these guidelines need to be followed. 

∙ Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prior to practice of telemedicine.

Application of Telemedicine

The RMP has been given the freedom to decide this depending on the complaints, the patient’s condition, the necessity for visual or aural interaction, and the resources that are available. The RMP retains the right to suggest an in-person consultation if he believes one is necessary and to go forward only following one.

Any appropriate telemedicine tool, including phone, video, LAN/WAN, internet, mobile/landline phones, chat platforms (like Facebook Messenger and WhatsApp), mobile apps, or other digital platforms (like Skype, email, and fax), can be used by RMPs (Registered Medical Practitioners) for patient consultations. The fundamental ideas of telemedicine hold true regardless of the communication medium employed. Based on the manner of communication, the timing of information transmission, the goal of the consultation, and the type of interaction—between a registered nurse and patient/caregiver or between an RMP and another RMP—telemedicine applications can be divided into four fundamental categories.

Guidelines for Telemedicine in India

An RMP is in a good position to determine if an in-person assessment is required or if a technology-based consultation will suffice. The practitioner must use appropriate judgement and not cut corners when it comes to patient care.

Seven factors must be taken into account before starting any consultation via telemedicine.

Seven Elements to be considered before any telemedicine consultation

1       Context

2       Identification of RMP and  Patient

3       Mode of Communication

4        Consent

5       Type of Consultation

6         Patient Evaluation

7         Patient Management

Patient and RMP identification– Anonymous teleconsultations are not allowed. At the onset of the consultation, the RMP is required to provide his identification and qualifications. Additionally, the patient’s name, age, and identity must be expressly verified by the RMP.

 

Consent-Consent is assumed once the patient starts the teleconsultation. The patient must give approval before the RMP can start a teleconsultation. The patient may give this clear consent by texting, emailing, or making his intention known over the phone or via video.

Ethics and secrecy– RMPs are required to follow the same medical ethics as stipulated in the Indian Medical Council (IMC) Act. These principles include upholding professional standards to protect patient privacy and confidentiality. This mandate encompasses their utilisation of technology services in addition to their clinical practice. When using technology services, RMPs should proceed with a reasonable degree of caution to avoid violating patient confidentiality or privacy. 

Documentation- As needed for in-person consultations, the RMP is in charge of keeping track of the teleconsultation, patient information, and prescription information. Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations.

In the case of Deepa Sanjeev Pawaskar and Others v. State of Maharashtra, a new mother went to the hospital the day after she gave birth, experiencing significant vomiting. The doctor gave her treatment recommendations over the phone without properly diagnosing her after a nurse checked her. The doctor’s prescription of medication without a complete medical evaluation was deemed irresponsible by the Bombay High Court, as the patient eventually died from a pulmonary embolism.

In another case involving actor Sushant Singh Rajput’s death, the prescription of clonazepam via teleconsultation was contested in court. Since clonazepam is on the prohibited list, its procurement through telemedicine was deemed illegal, according to the Telemedicine Practice Guidelines.

Types of the consultation

First consultations and follow-up consultations are the two categories of patient consultations.
When a patient is seeking teleconsultation for the first time without having previously had an in-person consultation, an RMP may only have a limited understanding of them. But if the initial consultation occurs through video, RMP can make far better decisions and, as a result, offer considerably better guidance, including more medications, if necessary. On the other hand, if the RMP has previously visited the patient in person, there may be more thorough in the patient’s care.

First time Consult- there are three condition when the consult is considered as first time consult 

• The patient is consulting with the RMP for the first time; or 

• The patient has consulted with the RMP earlier, but more than 6 months have lapsed since the previous consultation; or 

• The patient has consulted with the RMP earlier, but for a different health condition

Follow-up Consult(s)- 

∙ The patient is consulting with the same RMP within 6 months of his/her previous inperson consultation and this is for continuation of care of the same health condition. 

However, it will not be considered a follow up if:

 ∙ There are new symptoms that are not in the spectrum of the same health condition; and/or

 ∙ RMP does not recall the context of previous treatment and advice

The guidelines for telemedicine consultations in emergency situations, highlighting the following key points:

1. Emergency Consultations via Telemedicine:
   • Telemedicine can be used for emergencies when no alternative in-person care is available.
   • RMPs (Registered Medical Practitioners) should provide their best judgment in such situations to offer assistance.
2. Limitations of Telemedicine in Emergencies:
   • Telemedicine should only be used for immediate first aid, life-saving measures, counseling, and advice on seeking further care.
   • It is not a substitute for in-person care when it is available.
3. Encouragement for In-Person Care:
   • Even in emergencies where telemedicine is used initially, the patient should be advised to seek in-person consultation with an RMP as soon as possible.

Rules on the prescription of the medicines

The Registered Medical Practitioner (RMP) must use the same degree of professional judgement and accountability when prescribing medication through telemedicine as they would in conventional, in-person consultations. Before writing a prescription, the RMP must make sure they have gathered enough data to make an accurate diagnosis or a provisional diagnosis. In telemedicine consultations, the same diagnostic method should be used if a situation calls for it in an in-person environment.

It is regarded as professional malpractice to provide drugs without a diagnosis or a tentative diagnosis. This suggests that, using the medical data acquired, the RMP must be convinced that writing a prescription is in the patient’s best interests.

There are certain limitations and the restriction in prescribing the medicine in the telemedicine. The categories of medicines that can be prescribed via tele-consultation will be notified in consultation with the Central Government from time to time. The categories of medicines that can be prescribed are listed below:

Here is a table summarizing the matrix of permissible drug lists based on the type and mode of telemedicine consultation:

List Group	Mode of Consultation	Nature of Consultation	List of Medicines
O	Any	Any	List O1: Common over-the-counter (OTC) medications like Paracetamol, Oral Rehydration Solution (ORS), Antacids. Includes medicines needed in emergencies.
A	Video	First Consultation, Follow-up (for continuation of medications)	List A2: Medications requiring diagnosis via video, such as antifungals for Tinea Cruris, Ciprofloxacin eye drops for Conjunctivitis, or refills for chronic conditions like Diabetes, Hypertension, and Asthma.
B	Any	Follow-up	List B3: Add-on medications for optimizing existing conditions, e.g., adding Enalapril for hypertension when Atenolol is insufficient.
Prohibited	Not to be prescribed	Not to be prescribed	Schedule X drugs (as per the Drug and Cosmetic Act and Rules) and narcotic/psychotropic substances listed under the Narcotic Drugs and Psychotropic Substances Act, 1985, such as Morphine, Codeine, and Anti-Cancer drugs.

In the present scenario there are many challenges and the risk can be seen, they are-

• Inadequate physical examination– The capacity to conduct physical examinations, which are essential for diagnosing specific illnesses, is restricted by telemedicine. Virtual consultations are unable to provide the direct observation or palpation that certain symptoms may require. Serious diseases that need in-person evaluation may be misdiagnosed or delayed as a result of this restriction. Telemedicine also makes it more difficult for Dr. Arjun to perform a comprehensive physical examination in the circumstance that is presented. A significant heart problem or a muscle injury could be the cause of the chest ache Ramesh mentioned. The possibility of misdiagnosis exists if one is unable to conduct a physical examination or employ diagnostic instruments such as an ECG.
• Data Privacy and Confidentiality Concerns- Telemedicine involves the transmission of sensitive patient data over the internet. Ensuring the security of digital communication platforms and compliance with data protection laws is essential. There is a risk of data breaches, hacking, or unauthorized access to patient information, which can lead to privacy violations and legal liabilities for healthcare providers.
•  During the consultation, Ramesh shared sensitive health information, including his history of hypertension and diabetes. Dr. Arjun used a generic video-calling platform that doesn’t guarantee end-to-end encryption, raising concerns about data security and patient confidentiality. If Ramesh’s health information is compromised or accessed by unauthorized parties, it could result in privacy violations and legal liability for Dr. Arjun.
• Right to privacy is the fundamental right given to every citizen of India under Article 21 in the part III of the Indian Constitution. Therefore it becomes the challenge and the concern while performing telemedicine.

Telemedicine-specific guidelines, and sectoral regulations.

In India, data protection for telemedicine is managed through a combination of general privacy laws, telemedicine-specific guidelines, and sectoral regulations.

1. Information Technology Act, 2000 (IT Act)- The IT Act is the primary law that governs data protection and privacy in India. It includes provisions for securing sensitive personal data and handling breaches. Some important provision related to this includes-

Section 43A: Requires entities to implement reasonable security practices and procedures to protect sensitive personal data or information (SPDI). SPDI includes health information, which is considered sensitive under the IT Act. Any health-related data collected during a telemedicine consultation must be protected in compliance with SPDI rules.

If a telemedicine platform fails to do so and a data breach occurs, it may be liable for damages.

Section 72A: Penalizes unauthorized disclosure of personal information obtained under a contract. In telemedicine, if healthcare providers or telemedicine platforms disclose patient data without consent, they could face penalties.

2. Digital Personal Data Protection Act, 2023

The Digital Personal Data Protection Act, 2023 (DPDP Act) was enacted to address the growing concerns about data privacy and digital security in India. Its development was driven by the need for a comprehensive legal framework to protect personal data in the age of digital transformation, including the rapid expansion of telemedicine after Justice K.S. Puttaswamy case 2017.  The Act serves as a cornerstone for safeguarding patients’ privacy in telemedicine, ensuring the secure handling of sensitive health information, and building public trust in digital healthcare services.

Key provisions of this Act in terms of telemedicine

• Rights of Data Principals (Patients) – Patients, as Data Principals, have specific rights under the Act, including the right to access, correct, and erase their personal data. These rights ensure patients have control over their health data shared during telemedicine consultations.
• Obligations of Data Fiduciaries (Telemedicine Providers) – Telemedicine platforms and healthcare providers are considered Data Fiduciaries, who must ensure that personal data is collected, processed, and stored securely. Data processing should be based on the consent of the patient or for legitimate purposes such as medical treatment. Providers must inform patients in the event of a data breach and take measures to protect against unauthorized access.
• Consent Management– Explicit consent is required from patients before their personal data can be collected and processed during telemedicine consultations. Patients should be informed about the nature of the data collection and its intended use.
• Data Security and Breach Notification – The Act mandates the implementation of appropriate data security measures to protect personal health information. In case of a data breach involving patient data, telemedicine providers must notify both the affected individuals and the Data Protection Board of India.
• Data Retention and Erasure – Telemedicine providers are required to retain patient data only as long as necessary for medical or legal purposes and should erase it once the purpose is fulfilled, unless otherwise required by law.
• Exemptions for Public Health and Emergencies – Certain exemptions allow for the processing of personal data without patient consent in cases of public health emergencies or to comply with legal obligations, which is relevant for telemedicine in handling urgent medical situations.

Importance of the Act in Telemedicine

The DPDP Act establishes a legal framework that helps ensure patient privacy, data security, and trust in telemedicine services. It enables healthcare providers to deliver virtual consultations while complying with stringent data protection standards. This is crucial for:

• Protecting Patient Confidentiality: Safeguarding sensitive health information shared during telemedicine consultations.
• Building Trust: Encouraging patients to utilize telemedicine services by ensuring their data is handled responsibly.
• Regulatory Compliance: Helping telemedicine platforms meet legal requirements for data protection, thereby avoiding penalties and reputational damage.

National Digital Health Mission (NDHM) Guidelines – The NDHM aims to create a digital health ecosystem in India, promoting the integration of digital health records while ensuring data privacy. The Data Protection Measures taken by this mission are-

• Health ID Creation- Patients can create a Health ID to access their digital health records, with their consent required to link telemedicine records to this ID.
• Data Sharing Consent- Patients have control over who can access their health data, ensuring that telemedicine records are shared only with authorized entities.
• Security Standards- The NDHM guidelines set out data protection standards for entities involved in digital health, including telemedicine platforms, ensuring compliance with privacy regulations.

Informed Consent and Patient Awareness-   Patients may not fully understand the limitations and risks associated with telemedicine. It is the responsibility of healthcare providers to obtain informed consent and explain that telemedicine may not be suitable for all conditions. Inadequate informed consent could lead to legal disputes if complications arise from telemedicine-based treatment or if patients claim they were not made aware of the risks.

In the present scenario, Dr. Arjun did not adequately explain the risks and limitations of a telemedicine consultation to Ramesh, who may not fully understand that an in-person examination might be more appropriate for his symptoms. Without proper informed consent, Ramesh was not aware of the potential risks associated with relying solely on a virtual consultation.

Consent can be implied or the explicit.

“If, the patient initiates the telemedicine consultation, then the consent is implied

An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation. An Explicit consent can be recorded in any form. Patient can send an email, text or audio/video message. Patient can state his/her intent on phone/video to the RMP (e.g. “Yes, I consent to avail consultation via telemedicine” or any such communication in simple words). The RMP must record this in his patient records”

Technological Barriers– Telemedicine requires reliable internet connectivity and access to appropriate digital devices, which may not be available to all patients, especially in rural or remote areas. Poor internet connectivity, lack of digital literacy, or inadequate technology can hinder effective communication between the provider and the patient, potentially compromising the quality of care.

Ramesh lives in a rural area with limited internet connectivity. The video call was frequently interrupted, making it difficult for Dr. Arjun to get a clear understanding of Ramesh’s condition. Additionally, Ramesh lacks experience with digital devices, further complicating the consultation process. Poor video quality and lack of digital literacy could result in miscommunication, leading to incorrect treatment decisions.

Standard of Care and Liability- The standard of care expected in telemedicine can differ from traditional in-person consultations. Establishing a consistent standard across various platforms is challenging. Healthcare providers may face difficulties in defending their actions in malpractice claims if the standard of care in telemedicine is not well-defined or understood. 

The standard of care in telemedicine can be difficult to establish, as it differs from traditional in-person visits. Dr. Arjun’s treatment decisions based solely on virtual communication may not meet the same standards as those expected in physical consultations. If Ramesh’s condition deteriorates due to a delayed or incorrect diagnosis, Dr. Arjun could face allegations of negligence, resulting in civil liability or disciplinary action by medical regulatory authorities.

Prescription Regulations– Certain medications may require an in-person consultation before they can be prescribed, or may be restricted in telemedicine settings. Telemedicine guidelines often specify which types of drugs can be prescribed remotely. Providers may unintentionally violate prescription laws or expose patients to risks if they prescribe medications that require more stringent monitoring.

In the present scenario, Dr. Arjun prescribed medication to Ramesh based on a remote consultation. Some medications, particularly those for serious conditions, require in-person verification before prescribing. The guidelines for which medications can be prescribed via telemedicine may not always be clear. If Dr. Arjun prescribes medication that has serious side effects or requires monitoring, he could be held liable if Ramesh experiences adverse effects.

Measures can be take

Way forward

A well-organised legal framework, better digital infrastructure, and increased patient involvement are necessary for the future of telemedicine in India. To protect patient privacy and data security, telemedicine must successfully implement the Digital Personal Data Protection Act, 2023. Wider accessibility can be ensured by combining easily accessible and multilingual telemedicine platforms with increased internet connectivity, particularly in remote areas. Furthermore, insurance coverage for telemedicine services will encourage its integration into mainstream healthcare, and standardised training and certification for practitioners would guarantee quality. By taking these steps, telemedicine can develop into a safe, dependable, and essential part of providing healthcare.

Conclusion on Telemedicine in India

Telemedicine has emerged as a transformational technology in India, overcoming healthcare access gaps and allowing for rapid medical treatment in even the most rural places. As the use of telemedicine grows, it is critical to maintain the highest levels of professional ethics, patient care, and data protection.
Patient data protection and privacy must continue to be a priority in telemedicine practices. Healthcare practitioners can instill patient confidence while encouraging innovation in healthcare delivery by following frameworks such as the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, the IT Act, and growing data protection regulations. All stakeholders—medical practitioners, technology providers, and policymakers—are responsible for developing an ecosystem in which telemedicine The responsibility lies with all stakeholders—medical practitioners, technology providers, and policymakers—to create an ecosystem where telemedicine thrives without compromising patient rights. Through robust compliance, transparent processes, and secure technologies, India can lead the way in delivering equitable, ethical, and privacy-conscious healthcare solutions. Telemedicine is not just the future of healthcare; it is a commitment to leveraging technology responsibly for the betterment of society.