Introduction
With the passage of time, technological advancements have had a profound impact on the healthcare sector. Telemedicine, an emerging technology in the healthcare sector has led to a great change in the way healthcare services are provided where distance is a crucial and limiting factor. Access to healthcare facilities such as in-person consultation is a constraining factor in India primarily due to wide geographical distance and inadequate infrastructural resources.[i]
Presently in the wake of COVID-19, the Indian Ministry of Health and Family Welfare (MoH&FW) along with NITI Aayog has fostered guidelines on telemedicine[ii] in order to constructively meet ends during such a crisis. This move further led to provide legal validity to the practice of telemedicine in India which was long overdue ever since the formal introduction of telehealth services back in the year 2000.[iii]
The 2019 Mckinsey Report predicts the practice of telemedicine can aid India in saving up to $10 billion.[iv] The published guidelines should aim to provide the aforesaid cost-savings and socio-economic benefit to the Indian health sector. Keeping this in mind, the article provides an overview of the challenges and loopholes in the guidelines, concluding with recommendations.
Technological, Legal & Ethical Obstacles While Implementing Telemedicine Practice in India
Telemedicine promises a broad spectrum of benefits however, there are certain significant problems that tend to hamstring its adoption and implementation.
Technology Platforms: Privacy and Data Security Concerns
In a typical set-up of telemedicine consultation, exchange of patient’s information takes place through different modes. The 2020 guidelines provide for three basic modes of communication i.e. audio, video and text messages. Firstly, the tools for communication prescribed in the guidelines are not exhaustive in nature and extend to include casual chat platforms such as WhatsApp, Google Hangouts and Facebook. Specialized platforms such as mfine, Practo, Lybrate which are uniquely outlined to provide telemedicine services[v] are also mentioned within the modes of communication. However, permitting the use of casual modes of communication undermines the professional privacy and confidentiality component associated with a patients’ medical records. Moreover, telemedicine platforms such as mfine in their ‘Use of Services’ provides for patients’ data storage services which includes display of patients’ medical information history, diagnostic reports, prescriptions, etc.[vi] Such service providers who engage in more than just facilitating communication between the Registered Medical Practitioner and patients need to be governed by a uniform set of policies as it has been observed that the terms and conditions for use of these services vary from platform to platform. The ambiguity and lack of clarity within the guidelines regarding the aforementioned aspects could have a bearing on the rights of providers as well as users, this would altogether affect the future regulatory environment of telemedicine in India.
The Constitution of India guarantees privacy as a fundamental right to all its citizens[vii] and the same fundamental civil right extends to cyberspace under existing data protection rules[viii] and provisions.[ix] The concept of privacy is relevant now more than ever, particularly during this period where most of our daily and crucial activities have made the move to the virtual world.[x] Since the outbreak of COVID-19, there have been several instances of cyberattacks, wherein hackers are penetrating digital platforms and applications through methods of phishing, malware attacks, etc. due to the heightened dependence on the same.[xi]
Digital Health Ecosystem: Issues in Collection and Storage of Medical Records
The medical records and health information of an individual are sensitive in nature as it reveals confidential details of an individual’s life. In India, legislations such as the Information Technology Act, 2000[xii], Data Protection Rules, 2011[xiii] provide that medical records and history as well as physical, psychological and mental health conditions form a part of ‘sensitive personal data or information’ (SPDI). The pending ‘Personal Data Protection Bill, 2019’, under section 3(36) provides that the ‘health data’ of an individual constitutes ‘sensitive personal data’.[xiv]
Principles of public policy such as upholding ‘the right to privacy’ in collaboration with ICT and the health sector are vital for successfully scaling up telemedicine. However, the guidelines do not delve into the details on the specific obligations that a Registered Medical Practitioner or telemedicine platforms need to take into consideration to maintain absolute privacy and confidentiality of patient records. They merely assert the adherence to the norms of patient privacy and confidentiality under the relevant provisions of data and privacy laws in the country. Another loophole observed is the scant mention of directions on anonymization of health data while transferring data from the patient to RMP or through telemedicine platforms.
Inadequacies of such detailed specifications can lead to mishandling and leakage of medical records that can affect an individual’s life in ways such as access to credit, admission to educational institutions, and his/her ability to secure employment and obtain insurance. In situations wherein hospitals are providing telemedicine facilities,[xv] it is imperative that suitable norms for patient privacy and confidentiality are maintained especially in cases where hospitals have tie-ups with other healthcare centres. In the aforesaid case, drafting contracts or providing for storage of patient medical records as per essential privacy standards is a prerequisite.[xvi]
While deploying services of telemedicine, there is a need to strike a balance between privacy concerns and quick access to health services. It is also important to ensure that socio-economic benefits accrue to the public by enhancing patient-doctor communication. Further such communication underpinned by the required medical records will aid in providing better diagnosis of the patient. Therefore, it becomes binding on authorities to authorize proper storage of such sensitive records.[xvii] Supplementary guidelines such as the Electronic Health Records (EHR), 2016 which was formulated as a living document early in 2013 states standards that electronic health exchanges will have to adhere to, directions providing syntactic and semantic interoperability between health informatics, etc. [xviii]
The scope of EHR, 2016 is very narrow and does not take into account the creation of legal, regulatory or administrative framework. Employing the use of EHR complements the service of telemedicine as it serves as a centralised source of patients’ medical records. Thereby, it ensures to provide legible and well organized documentation which will enable instant access to information in the digital era. Perhaps with the enforcement of the pending Personal Data Protection Bill, 2019, a clearer picture will be painted pertaining to storage of health data by ‘Data Fiduciary’ or the ‘Data Authority of India’, as the guidelines do not throw light on storage of health data at a national level. The only insight observed from the guidelines is that the duty of the RMP is to ensure security and maintenance of their patients’ medical record.[xix]
Identification of Potential Legal and Ethical Concerns
Matters of medico-legal liability and risks involved are among the many pertinent issues that continue to pose a roadblock to the uptake of telemedicine. Due to the absence of a comprehensive national regulatory framework, medical professionals are reluctant to engage in the use of telemedicine.[xx] In 2018, the Bombay High Court delivered a judgement which many medical practitioners observed and interpreted it to be ‘against the practice of teleconsultation’.[xxi] Several national medical associations raised a hue and cry berating the judgement and called for adequate regulations to provide legal validity to ‘telemedicine’ practices in the digital health sector.[xxii]
With the introduction of the ‘Telemedicine Practice Guidelines, 2020’, an air of legal legitimacy is attributed to its practice. The guidelines provide a general outline specifying the RMP’s duty to execute appropriate standards of care, conduct diagnosis and consultation based on his prudent professional judgement.[xxiii] However, in a virtual set-up the risk of misdiagnosis is greater vis à vis a physical consultation, the duty of standard of care should therefore be administered at a higher level to avoid medical negligence cases.[xxiv] The absence of the aforesaid and a precise set of principles detailing the nature of consultation over telemedicine platforms could result in frivolous legal actions against the RMP.
Further, identification measures and informed consent are crucial factors in the process of virtual medical consultation as it deals with SPDI.[xxv] As per the guidelines, the safety checks deployed include requiring the RMP to always confirm the identity of the patient .They further state that consent could either be ‘explicit’ or ‘implied’ if the teleconsultation is initiated by the patient’.[xxvi]The RMP’s identity should also be known to the patient. Individuals engaging in teleconsultations must be aware about the risk, benefits, nature and consequences of the same. This awareness could be generated primarily by the concept of electronic informed consent.[xxvii] Other vital factors in order to promote awareness with regards to telemedicine particularly in rural areas is by educating the masses on digital literacy and digital healthcare with the aim to encourage the usage of telemedicine.[xxviii]
Broadband Connectivity: Infrastructural Challenge in a Resource Constrained Environment
According to the published guidelines, the greatest advantage that telemedicine could have is in rural areas. The World Bank states that India has ‘0.8 physicians per 1000 persons’[xxix] while the National Health Mission estimates that the doctor patient ratio in rural areas is six times lower in comparison to urban areas.[xxx] However, the issue of ‘Broadband connectivity’ still persists as the aforesaid has a major role to play in delivering uninterrupted access to telemedicine services. The Centre in 2019 rolled out a national broadband mission with the objective of providing universal broadband access to over 6, 00,000 villages across India in the forthcoming 3-4 years.[xxxi] The same has faced criticism and disapproval from the telecom sector as it has been facing financial woes. India’s goal to achieve universal broadband connectivity across the country by 2022 is ‘highly unrealistic’ [xxxii] which indicates that the telecommunication sector poses to be both, a technological as well as an infrastructural barrier to achieve the goals of telemedicine.
The Way Forward: Envisaging the Future Model of Telemedicine in India
Telemedicine has documented significant benefits in the digital health sector however in India, its process and implementation are still at the exploratory stage. All in all telemedicine promises various perquisites to the people. It is therefore recommended that India should adopt a comprehensive medico-legal legislation to address the challenges faced by both users and providers of telemedicine services.[xxxiii] In 2017, the MoH&FW proposed a draft legislation which focused on healthcare data privacy, confidentiality, security and standardisation[xxxiv] named ‘Digital Information Security Healthcare Act’ (DISHA) however, the former is expected to be subsumed in the expected Personal Data Protection Bill, 2019 which appears to be counterintuitive.[xxxv]
The introduction of a separate act to ensure safety of patient health records which falls under ‘SPDI’ will ensure that equivalent level of data security is ascribed to it irrespective of where the data is being transferred.[xxxvi] Initiatives should be undertaken to establish a database that exclusively stores EHRs at a national level and should aim to impart greater standards of security, privacy and confidentiality. It is advisable that telemedicine platforms are designed in a manner which is user-friendly such as offering services in regional languages to overcome language barriers. The guidelines should mention binding system requirements and policies that such platforms or service providers need to comply with to ensure that there is no contravention of existing laws. Lastly, the guidelines should focus on providing a detailed, specific set of key terms, definitions and principles to avoid ambiguity as well as misinterpretation.
Conclusion
Fortune favours the prepared.[xxxvii] It is therefore necessary for India to take a proactive approach and embrace a powerful digital health service system. Observing transparency in data governance, safeguarding the relationship between internet rights and human rights could serve as a starting point while exploring the role of data in digital health governance.[xxxviii] Rapid developments in the digital space should urge governments to adopt the concept of digital constitutionalism as the world inches towards adapting technology in routine activities.[xxxix] The practice of telemedicine is just the tip of the iceberg while considering the numerous advantages the digital health sector could offer in the near future.
[i] Board of Governors (in supersession of the Medical Council of India), Telemedicine Practice Guidelines 2020, MoH&FW (Mar.25, 2020),https://www.mohfw.gov.in/pdf/Telemedicine.pdf.
[ii] Id.
[iii] K. Ganapathy, COVID-19 enhances reliance on Telemedicine ,The Hindu (Apr.19, 2020), https://www.thehindu.com/news/national/tamil-nadu/covid-19-enhances-reliance-on-telemedicine/article31378946.ece.
[iv] Noshir K et al., Report on Digital India ‘Technology to Transform a Connected Nation 86-87, Mckinsey Global Institute (2019), https://www.mckinsey.com/~/media/mckinsey/business%20functions/mckinsey%20digital/our%20insights/digital%20india%20technology%20to%20transform%20a%20connected%20nation/digital-india-technology-to-transform-a-connected-nation-full-report.ashx.
[v] Sreenidhi Srinivasan, Coronavirus has become the booster shot that telemedicine was waiting for in India, QuartzIndia (Apr.6, 2020),https://qz.com/india/1833374/coronavirus-to-boost-telemedicine-apps-mfine-and-practo-in-india/.
[vi] mfine Services, Terms of Use Agreement ( Apr. 27 , 2020 ), https://www.mfine.co/terms-of-use/.
[vii] K.S Puttaswamy v. Union of India, (2017) 10 SCC 1 (India).
[viii] Rule 3, Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011, Gen. S. R. & O. 313(E) (India).
[ix] Section 43A, Information Technology (Amendment) Act, 2008, No.10, Acts of Parliament, 2009 (India).
[x] Danielle Citron and Mary Anne Franks, Cyber Civil Rights in the Time of COVID-19, Harv. L. Rev. Blog
[xi] Algirde Pipikaite and Nicholas Davis, Why cybersecurity matters more than ever during the coronavirus pandemic, World Economic Forum(Mar.17, 2020), https://www.weforum.org/agenda/2020/03/coronavirus-pandemic-cybersecurity/.
[xii] Supra note 9.
[xiii] Supra note 8.
[xiv] The Personal Data Protection Bill 2019, Lok Sabha, 373 of 2019 (2019).
[xv] Rhythma Kaul , With 105 Centres , gov’t spreads telemedicine centres across the country, Hindustan Times ( Aug.17, 2016), https://www.hindustantimes.com/india-news/with-105-centres-govt-spreads-telemedicine-network-across-country/story-UDwyqZRniQOjzJg9MOzk8I.html.
[xvi] Ajay Garg, Legal Issues in Telemedicine, The Diplomatic Square (May. 19, 2019), https://www.diplomaticsquare.com/legal-issues-in-telemedicine.
[xvii] WHO, Telemedicine: Opportunities and Developments in Member States: Report on the second global survey on eHealth, World Health Organization (2009),https://www.who.int/goe/publications/goe_telemedicine_2010.pdf.
[xviii] Department of Health and Family Welfare, Electronic Health Records, 2016, Gov’t of India (Dec.30, 2016), https://www.mohfw.gov.in/.
[xix] Rule 3.7.1, Telemedicine Practice Guidelines 2020, MoH&FW (Mar.25, 2020), https://www.mohfw.gov.in/pdf/Telemedicine.pdf.
[xx] Ashwin Sapra et al., DIAL A DOCTOR: A Look at the Telemedicine Practice Guidelines, 2020, INDIA CORPORATE LAW (Apr. 27, 2020), https://corporate.cyrilamarchandblogs.com/2020/04/dial-a-doctor-a-look-at-the-telemedicine-practice-guidelines-2020/.
[xxi] Deepa Sanjeev Pawaskar and Anr v. State of Maharashtra, Criminal Anticipatory Bail Application No.513 (2018) Criminal Appellate Jurisdiction (India).
[xxii] Suraksha P, Telemedicine Has No Legal Backing , Fraternity Calls For Regulation, The New Indian Express
(Sept.17,2020) , https://www.newindianexpress.com/cities/bengaluru/2018/sep/17/telemedicine-has-no-legal-backing-fraternity-calls-for-regulation-1872965.html.
[xxiii] Rule 4, Framework for telemedicine: Essential Principles Telemedicine Practice Guidelines 2020, MoH&FW (Mar.25, 2020), https://www.mohfw.gov.in/pdf/Telemedicine.pdf.
[xxiv] Giuoli Nittari et al., Telemedicine Practice: Review of the Current Legal and Ethical Challenges, Mary Ann Liebert Inc. (Feb. 12, 2020), https://www.liebertpub.com/doi/10.1089/tmj.2019.0158.
[xxv] Dr. Milind A., Darren P., Shreya S., Digital Health in India : Legal Regulatory and Tax Overview ,Nishith Desai Associates (Apr.2020), http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/Digital_Health_in_India.pdf.
[xxvi] Rule 3.2, Telemedicine Practice Guidelines 2020, MoH&FW (Mar.25, 2020), https://www.mohfw.gov.in/pdf/Telemedicine.pdf.
[xxvii] Christine Coughlin, E-Consent: Can Informed Consent Be Just a Click Away, 50 Wake Forest L. Rev. 381 (2015).
[xxviii] FE Online, Digital India goes rural: Modi’s ‘DigiGaon’ to bring villages on Wi-Fi Internet to boost literacy, incomes, Financial Express (May 22, 2018), https://www.financialexpress.com/economy/digital-india-goes-rural-modis-digigaon-to-bring-villages-on-wi-fi-internet-to-boost-literacy-incomes/1176688/.
[xxix] Deepankar B. and Priyanka S., In South Asia , Lanka leads and India lags in infrastructure, medical response to Covid-19, The Wire (May.11, 2020) , https://thewire.in/health/in-south-asia-lanka-leads-and-india-lags-in-infrastructure-medical-response-to-covid-19.
[xxx] Vikram Thaploo, Telehealth as a tool to achieve universal healthcare, Healthcare Radius (Mar.7, 2020),https://www.healthcareradius.in/25376-telehealth-as-a-tool-to-achieve-universal-healthcare.
[xxxi] Muntazir Abbas, Centre launches national broadband mission, envisages an investment of Rs.7 lakh crore, The Economic Times (Dec.17, 2019),https://telecom.economictimes.indiatimes.com/news/govt-launches-national-broadband-mission/72843402.
[xxxii] Muntazir Abbas, Universal broadband connectivity by 2022 unrealistic: Telecom Group, The Economic Times (Feb.28, 2020),https://telecom.economictimes.indiatimes.com/news/universal-broadband-connectivity-by-2022-unrealistic-telecom-group/74392704.
[xxxiii] Maurice Mars, Medicolegal, ethical and regulatory guidelines pertaining to telehealth in Fundamentals of Telemedicine and Telehealth 297-99 (Shashi G ed., 2019).
[xxxiv] Priyanka Anand and Vasudha Luniya, DISHA — India’s probable response to the law on protection of digital health data, In House Community (Jul.24, 2018), https://www.inhousecommunity.com/article/disha-indias-probable-response-law-protection-digital-health-data/.
[xxxv] Trishi Jindal, India’s Covid-19 response calls for Urgent Data Disclosure Norms, Vidhi Centre for Legal Policy (Apr.29, 2020) https://vidhilegalpolicy.in/2020/04/29/indias-covid-19-response-calls-for-urgent-data-disclosure-norms/.
[xxxvi] Supra note 18.
[xxxvii] Sheetal Ranganathan,.Mission Resilience: A Clarion Call for India’s future health , ORF ONLINE (May 1, 2020), https://www.orfonline.org/expert-speak/mission-resilience-a-clarion-call-for-indias-future-of-health-65506/.
[xxxviii] Urs G. et al., Towards Digital Constitutionalism? Mapping Attempts to Create an Internet Bill of Rights, Research Publication no. 2015-15 Berkman Center for Law and Society 15, 16 (2015).
[xxxix] Supra note 37.
Authored by Karen Barreto and Neha Mehta, students of Kirit P. Mehta School of Law, NMIMS University, Mumbai. This blog is part of the RSRR Blog Series on Digital Healthcare in India, in collaboration with Nishith Desai Associates.