From a regulator’s point of view, an efficient, risk-based approach to regulating digital health technology will foster innovation of digital health products. Regulators must take a hands-off approach to lower-risk digital health technology, including software write Biplab Lenin, Partner, Cyril Amarchand Mangaldas – Pharmaceuticals, Healthcare and Life Sciences) And Meghna Bhaskar(Associate, Cyril Amarchand Mangaldas)
One of the first definitions of digital health was opined by Professor Eric Topol from the Scripps Institute of San Diego while describing the “Digital Human” in his 2012 book, “The Creative Destruction of Medicine” where he underscored the role of binary data to improve clinical medicine. In doing so, he married the field of bioinformatics, the study of genomics, proteomics and exosomics, with the field called biomedical informatics, the study of electronic personal health records. Today, Digital Health has expanded well beyond this definition to include telemedicine systems, e-diagnostics, robot-assisted surgeries, online delivery of medicine, wearables and medical devices embedded with software, AI-driven health apps, electronic health records, data visualization and analytics.
The growing rate at which technologies are disrupting and changing the healthcare sector is indicative of a more fundamental shift in the delivery and receipt of healthcare services. COVID-19 and the pandemic catalysed a revolution which had been gearing to disrupt the healthcare sector since the Internet Boom of the ‘90s. The technological revolution of the 1990s brought on many new trends in the world of medicine – The adoption of personal computers gave rise to ‘e-health’ and on attaining connectivity through networks, telemedical services appeared. ‘Health IT’ came to be defined as the management of electronic medical records and soon after, the rise of social and digital media paved the way for ‘Health 2.0’. With the rapidly developing market of smartphones and smartwatches, we have now entered the age of ‘Mobile Health’ or ‘m-Health’.
Digital Health, a broader over-arching concept, comprises all this and then some. It represents the cultural transformation led by disruptive technologies which enable healthcare service providers and patients access to objective data which culminates in an equal-level doctor-patient relationship rooted in shared decision-making and democratisation of care. Digital Health also signifies a shift in the point of care from hospitals to patients, a shift in the role of caregivers from one of authority to partnership, and a consequent change in the patient’s role from being passive to being self-managing and sharing responsibility. Overall, the coalescence of technology and healthcare promises to help hospitals, physicians and public health systems, just as much as it guarantees economies of scale for life science and medical device companies.
The promise of digital health is to improve the clinical as well as economic efficacy of digital tools to increase access to medicines and diagnostics by reducing healthcare costs on a population level for nations and groups. Digital health technologies empower consumers to make informed decisions about their health, within or outside traditional care settings and provide novel solutions for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions. Software and technologies assisting in diagnosis, treatment, storing and transfer of e-health records, precision medicine and preventive healthcare can enable more efficient clinical practice. Advancements in data analytics will also play a crucial role in addressing public health crises by providing immediate information on nearby treatment options and emergency help.[¹] Consumer technology and the recent popularity of e-pharmacies promises to improve last mile connectivity and make digital health products unprecedently accessible within, and across borders.
With demonstrated benefits of integrating technology with traditional financial systems and conventional modes of education, the healthcare sector seems to be the next industry staring down the barrel of a similarly disruptive gun. It is now tasked with deciding to swing from the old vine to the new, by relying on existing and emerging technologies to optimise costs, time, accessibility, precision and accuracy.
Telemedicine and Telehealth – Widening the Net of Healthcare Coverage
Telemedicine employs information and communications technologies to monitor and treat patients in lieu of in-patient visits. The adoption of telemedicine practices, commonly known as telehealth, promises to increase access to quality healthcare in the country’s remotest regions through virtual consultations with healthcare practitioners, particularly in instances of public health emergencies when brick-and-mortar facilities are either non-existent or occupied to full capacity. Technologies for online consultations have been scaled up significantly to assist clinicians in remotely diagnosing, monitoring, and caring for patients and advancing a healthcare system that prioritises the use of technology.
In furtherance of this objective, FICCI released a ‘Self-Regulatory Code of Conduct for e-Diagnostics in India’ in 2022 for tech platforms accepting customer requests for medical laboratories, clinical sample collection, transportation services, sample processing, reporting services, or report delivery. The Telemedicine Practice Guidelines, 2020 shed further light on the nature and manner of care that may be provided and provide guidelines for medical practitioners to practice telemedicine from any part of the country. The Guidelines also categorize medicines into four Lists – O, A, B and Prohibited – and specify which medicines may be prescribed in which situations. These guidelines have been incorporated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code) and are therefore binding on medical practitioners. Currently, the applicability of the Guidelines is limited to registered medical practitioners (RMP) registered by a state medical council under the National Medical Commission Act, 2019. Additionally, service providers rendering application services including telemedicine services using telecom resources provided by telecom service providers are required to register as an ‘Other Service Providers’ (OSP) with the Department of Telecommunications as per the OSP Regulations under the New Telecom Policy, 1999.
Health Apps, Wearables and the virality of ‘mHealth’
Macro data statistics help place digital health integration in perspective and reveal that with more than 90,000 new digital health applications being added to app stores in 2020, and an average of more than 250 apps being launched every day, the total tally of m-Health apps has risen to 350,000. General wellness apps form a vast majority of these apps which is evidenced by the significant adoption of wearables such as Fitbit and Jawbone.
Throughout the pandemic, there has been a proliferation of apps to track symptoms, apps to monitor the lateral flow of test data, and apps that act as vaccine passports. New and existing digital health solutions such as implantables and bio-sensors help with continuous, real-time monitoring of specific health conditions and have assisted in mitigating some of COVID-19’s health effects. ‘Point-of-care Diagnostics’ (POCD), with the help of such apps and medical devices, simplify complex diagnostic procedures to provide immediate diagnostic results and allow users to communicate with health practitioners virtually, track general health indicators, and remotely manage their health condition and symptoms.
Digital Health is also focused on improving the care of patients with chronic health conditions and pre-empting the development of avoidable consequences such as strokes and heart attacks by aggregating health data on patients. Thereafter, the data points are subjected to data analytics with the help of predictive algorithms using evidence-based best practices and standards and deriving insights at an individual patient level.
Online Sale of Medicines – Emerging Market Models and Challenges
In 2021, the e-pharmacy market in India reached a value of USD 344.8 million and is estimated to grow at a CAGR of 63% to reach USD 3,657 million by 2022. In health insurance, the government’s e-healthcare initiatives, rapid internet penetration, and a change in disease patterns in India have paved the way for the widespread adoption of online pharmacies. Increased familiarity with digital modes of payment and services and the ability to rely on tech-based solutions are positive indicators signifies a narrowing of India’s digital divide. As per Deloitte’s Global TMT predictions, India’s smartphone penetration is expected to widen from 750 million to 1 billion users by 2026.[²] The government’s BharatNet Programme aims to fiberize all villages by 2025, propelling further adoption to assure last-mile connectivity for telehealth and telemedicine delivery.[³]
There are three possible market models for the growth of e-pharmacies in India – First, an inventory-based model where e-Pharmacies directly purchase in bulk from distributors which enables them to procure the drugs and medicines at a substantial discount and increasing profit margins; Second, a marketplace-based model based on an aggregator format or Third, a generic marketplace model such as Flipkart and Amazon. These models may evolve through existing brick-and-mortar chains establishing an online presence, or existing e-Commerce players entering the e-Pharmacy business, or through an evolution of existing models into online-offline hybrid models.
Given the high standards of care and consumer safety in healthcare regulations, the online sale of medicines must ensure proper compliance with existing applicable laws in the face of regulatory uncertainty. With the inter-state sale of drugs, there is a possibility that certain medicines valid in one state may not have a license in another. There is also ambiguity under Indian law regarding the legality of pharmacies receiving money prior to the delivery of medicines. Further, the online sale of drugs is accompanied by the risks of self-medication, particularly those of sale to minors or drug abuse where a single prescription may be used for multiple deliveries of drugs through different e-pharmacy websites. While obtaining a drug license is compulsory for the online sale of both, prescription and non-prescription drugs, OTC drugs may be sold online without a prescription.
The Indian judiciary has opted to ensure safe pharmacy practice after two writ petitions were filed in the Delhi and Madras High Courts successfully challenging the legality of online sale of drugs without prescriptions and cash memos[⁴] While the court acknowledged the possible risks of harmful self-medication and sale of unregulated medicines through online platforms, DCGI’s 2015 circular specifies that the Drugs and Cosmetic Rules, 1945 do not differentiate between the conventional and online sale and distribution of drugs.[⁵] Further, the DCGI issued an official letter in 2019 to enforce the 2018 order passed by the Delhi High Court in the Zaheer Ahmed case which prohibited the online sales of medicines without a valid license.
Unfortunately, India presently lacks a dedicated regulatory mechanism for the online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. In 2018, the Ministry of Health and Family Welfare (MoHFW) notified a draft to amend the Drugs and Cosmetics Rules, 1945 by proposing to incorporate a chapter on ‘Sale of Drugs by E-Pharmacy’, however, these Rules have not yet been given effect.[⁶]
This implies that though legal, e-pharmacies continue to operate in a regulatory vacuum but still require compliance with existing regulations applicable to the retail of medicines. Applicable restrictions on e-pharmacies include the prohibition of advertisement of any drugs on radio, television, internet, print or any other media and restrictions on narcotic and psychotropic drugs. Companies must ensure compliance with existing restrictions for the retail of prescription and scheduled drugs under the Drugs and Cosmetics Act, 1940 and the corresponding Rules to avoid regulatory scrutiny by authorities in the future.
Artificial Intelligence, Machine Learning and Big Data – The Building Blocks of Digital Health
Healthcare is no different from other areas of daily life where Artificial Intelligence (AI) and its subset, Machine Learning (ML) are intertwined – AI enables computers and mechanical devices to think like humans and perform tasks on their own by employing ML, which enables computer systems to develop intelligence. In the pharmaceutical and healthcare industries, AI and ML may be used to increase security, patient safety, and healthcare practitioners’ knowledge. It may also be used to assess medical imaging, forecast results, analyze medical or patient data, review the literature on healthcare, and offer treatment options. AI and ML also offer a range of possible uses in both, immediate and future clinical trials, including the collection and analysis of real-time data, seamless integration of data obtained from different phases, clinical research productivity, suggestions based on the actual performance of treatments, interventions in patient population, post-market surveillance and patient support.
Taken together, AI and ML refer to self-learning, dynamic technologies that recommend or make decisions. The goal is to create computer programs which can access data sets to be fed into algorithms for delivering increasingly accurate and precise results. By 2030, the market for artificial intelligence in healthcare is expected to rise to $187.95 billion, growing at a CAGR of 37% between 2022 and 2030.
Healthcare data is typically sourced from healthcare facilities having access to patient data, healthcare practitioners, surveys, technology platforms, health apps, social media platforms and clinical studies. Medical software including mobile apps, medical device data systems (electronic transfer, storage, display, or conversion of medical device data), medical image storage devices (store or retrieve medical images electronically) and medical image communications devices (transfer medical image data electronically between medical devices) collect and generate vast amounts of sensitive consumer data, including information about users’ reproductive lives, mental health, and genetics.
Real-time data can be efficiently leveraged with predictive AI models and analytical tools to reduce the probability and impact of human mistakes in data gathering and analysis through seamless interoperability with other databases and applications. This is notwithstanding the requirement of obtaining patient consent and maintaining neutrality by ensuring impartiality in data sets, which will presumably be one of the biggest challenges for AI and ML integration in mainstream healthcare. Data duplication, modalities and standardization in data collecting and processing, and the involvement of technology platforms and healthcare organizations are all concerns that must be addressed.
Currently, the regulatory framework for data is the Information Technology Act, 2000 and the Rules thereunder. Further, the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011 regulate sensitive personal data and information. This legislation and corresponding rules govern healthcare data as well. Further, the Digital Information Security in Healthcare Bill is a proposed bill providing a legal framework for anonymization and de-identification of digital health data. Additionally, the Electronic Health Record Standards for India, 2016 notified by MoHFW offers a set of optional standards for the protection, disclosure, privacy, and security of protected health information. Lastly, to solidify user control over personal health data, the Health Data Management Policy was framed under the National Digital Health Mission, 2020 which prescribed a consent framework to monitor the collection, storage, processing, and sharing of data and introduced the concept of an electronic consent manager to interact with users to obtain consent to access their health data, in addition to laying down the obligations of data fiduciaries.
Given the importance and complexity of healthcare data, the right methodology is essential to ensure that information is properly collected, saved, and used. While various policy initiatives have been taken to harness technology and build a strong healthcare infrastructure, the time has come for proper legislation to handle the sector’s overlapping challenges.
Use Cases of Blockchain in Healthcare – Not Just Another Brick in The Wall
Blockchain enables a holistic, efficient, and transparent ecosystem which stores and tracks data while ensuring immutability. These attributes make it a custom fit for the regulation of pharmaceuticals and healthcare. As per industry reports, the Blockchain healthcare market is estimated to grow to the tune of $3.49 Billion by 2025.[⁷]
The defining features of Blockchain are its decentralized network, transparency, and immutability. It achieves this by grouping encrypted data records into data blocks and distributing them across different participating systems in the network, resulting in a unique signature known as a hash. The blocks are immutable, and any tampering with the records will be notified to all participating users. Based on the level of security required, users may choose between the different types of blockchains – public, private and permissioned. In the context of healthcare systems, this implies that the patient will have a unique identity in the blockchain network, and any new clinical data added, will be stored with this unique identity in the EHR-integrated Blockchain network.
Several healthcare start-ups have adopted cloud-based personal health record management solutions running on secure blockchain networks. For example, Aimedis, a Belgian healthcare company, has developed the first healthcare platform with an integrated medical and scientific NFT marketplace in combination with a DeFi, governance, social, payment and utility token to develop a blockchain-backed medical ecosystem.[⁸] It uses a dual blockchain system of permissioned and permission-less blockchain systems to preserve data privacy and the transparency of smart contracts to facilitate secure data flow.
Blockchain may also be leveraged to regulate interactions between industry players and sectoral regulators. Such blockchain-enabled interactions take a step beyond the mere notarization of documents and facilitate the development of an end-to-end system wherein all records – product development, trials, licensure, production, and supply chains – are recorded on the blockchain network. Thus, in addition to patient records, operational data records of clinical establishments, licenses and compliance information may also be recorded in this manner. Notably, the rules of the Clinical Establishments (Registration and Regulation) Act 2010, mandate the maintenance and provision of Electronic Medical Record (EMR) for every patient for registration and operation of every clinical establishment.
Strategy, Laws and Regulation – An Overview of India’s Digital Health Initiatives
With the vision to create a national digital health ecosystem, India has a robust framework which supports universal health coverage in an efficient, accessible, inclusive, affordable, timely and safe manner. Since 2018, India has been a founding member of the Global Digital Health Partnership (GDHP) which is an international collaboration of governments, government agencies and multinational organizations including the World Health Organization (WHO), formed to support the effective implementation of digital health services.[⁹] The Ayushman Bharat Digital Mission (“ABDM”) was launched by the Government to integrate the country’s digital infrastructure and bridge the gap between stakeholders in the healthcare ecosystem. The mission calls for the creation of four registries – for doctors, health infrastructure, health IDs, and patient personal health information. Presently, over 21 crores of health IDs have been issued under the ABDM[¹⁰] In January 2022, with the launch of the ABDM Unified Health Interface, digital health companies and other participating entities have been given the green signal to build their services on top of it. Consultation with doctors, delivery of medicines, delivery of health services, and many such services can be done instantly, thereby increasing efficiency for organizations and affordability for patients.
The National Health Policy, 2017 was one of the first attempts by the Government to create a Digital Health Ecosystem in India by suggesting the establishment of a National Digital Health Authority and recommending the linking and integration of Aadhaar with individual health records. The Draft Digital Information on Security in Healthcare Act (DISHA), 2018 proposed the establishment of the National Digital Health Authority and Health Information Exchanges for ensuring electronic health data privacy, confidentiality, security and standardization in maintaining, storing, protecting, and transmitting health data. Complementing the Personal Data Protection Bill, and analogous to the Health Insurance Portability and Accountability Act (HIPAA), 1996 in the United States, DISHA makes a distinction between the types of data it regulates known as Digital Health Data (DHD) and associated personally identifiable information (PII). However, strict provisions proposed under DISHA relating to a ban on the commercialization of health data may create incongruency with the PDP Bill 2019 which allows for data process under specific circumstances.
The National Digital Health Blueprint, 2019 was released by the committee chaired by Shri J. Satyanarayana to give effect to the National Health Stack under a streamlined National Digital Health Mission, 2020 (NDHM) which recommended the creation of Aadhar-linked Health IDs, a federated architecture of data analytics based on the health data aggregated by Health Information Providers (HIP), a Healthcare Professionals Registry and Health Facility Registry in addition to a Consent Manager and Gateway for the seamless flow of data after obtaining patient consent. The data is stored in the National Health Stack which was introduced in 2018 to achieve ‘portability’ of healthcare by creating a centralized health record for all citizens to streamline the collection and effective management of health information. This data can be accessed not only by patients but players across the healthcare industry including hospitals, laboratories, and insurance companies. It also proposed the creation of master health data, personal health records for individuals, digital health IDs and health data directories, and a ‘coverage and claims platform’ for integrating health insurance programs into the system.
While the National Digital Health Blueprint recognises the federated architecture that is required to create a digital healthcare ecosystem, it funnels the focus on data protection and privacy and overlooks other regulatory aspects that may arise with the change in the new definition of medical devices. Drug-specific laws are not equipped to regulate the intangible nature of software and other evolving technologies in the healthcare sector. For example, under the Drugs and Cosmetics Act, 1940, ‘import’ is defined as “bringing anything into India” which implies that any software developed outside India may be deemed to be imported once it is used in India, making the software owner subject to Indian laws and disincentivising cross-border flow of innovative technologies. It is thus, imperative to calibrate domestic regulatory scrutiny with emerging global trends and ensure that unnecessary and disproportionate regulation does not inhibit the growth of innovative solutions in healthcare. To this effect, the United States has opted to not regulate certain medical software as medical devices under the 21st Century Cures Act, including software that supports administrative functions, encourages a healthy lifestyle, serves as electronic patient records, assists in displaying or storing data, or provides clinical decision support.
Access to not just healthcare, but quality healthcare is important. Tier 1 cities may have benefitted from the adoption of digital health, while access and integration of healthcare services remain low in Tier 2 and Tier 3 cities as well as rural and remote areas of the country which fall on the wrong side of India’s digital, economic and literacy divide. Thus, infrastructure needs to be developed to cater to the Indian population, considering the country’s demographic realities. Focused efforts by the government to bridge the digital divide in India will ensure a smoother transition from conventional modes of healthcare delivery to technology-enabled solutions which optimize costs and time and bring more people within the healthcare net.
Although the term Digital Health has been used in India for a while, COVID-19 emphasized the significance of virtual technology for access to medical experts, diagnostic services, disease treatment, and pharmaceutical distribution. While it is expected that the healthcare industry will undergo an exponential change in the short term, there will be challenges in terms of regulatory vacuum or implementation. Organizations may need to realign their goals by creating new business models to ensure the delivery of services is not only efficient and secure but also legally compliant.
From a regulator’s point of view, an efficient, risk-based approach to regulating digital health technology will foster innovation of digital health products. Regulators must take a hands-off approach to lower-risk digital health technology, including software. Traditional implementation of the premarket requirements may impede or delay patient access to critical evolutions of software technology, particularly those presenting a lower risk to patients. Improving the international regulatory environment for digital health products is also critical to fostering innovation domestically and increasing the availability of products that benefit the health of Indians and people of other nations.
 FDA Digital Health Innovation Action Plan – DH Action Pl (fda.gov) (March 26, 2020)
 TMT India Predictions 2022 | TMT Trends Analysis 2022 | Deloitte India
 TMT India Predictions 2022 | TMT Trends Analysis 2022 | Deloitte India
 Zaheer Ahmed v. Union of India W.P.(C) 11711/2018 & CM APPL. 45307/2018.
 No. 7-5/2015/Misc/(e-governance)/091 Dte. General of Health Services Office of Drugs Controller General (India) http://www.cdsco.nic.in/writereaddata/Online-Sale-dec-2015.pdf
 Notification G.S.R. 817 (E) dated August 28, 2018 (7).
 Blockchain Market in Healthcare Trends | Industry Growth2022 – 27 (mordorintelligence.com)
 Official Website, Aimedis
 GDHP (nhp.gov.in)
 Press Release dated April 5, 2022 at https://pib.gov.in/PressReleasePage.aspx?PRID=1813660