This article is written by Ridhima Purwar, from Symbiosis Law School, Noida. The article extensively talks about the healthtech sector in India with the regulations governing it.
Healthtech is the fastest-growing sector in the healthcare world. Healthtech, the term itself encapsulates this evolution, clearly referring to the intersection between healthcare and technology. Though it is broadly described as any technology which enables healthcare products and services that can be delivered or consumed outside of a hospital or physician’s office, the healthtech companies also provide mobility and information technologies to improve healthcare delivery while decreasing its costs. These companies aim to optimize patient-centric healthcare through solutions like cloud computing, internet services, and social mobility.
Indian healthtech and the pandemic
The COVID-19 outbreak not only brought the global economy- it exposed the inadequacies of the developed world’s health systems in addressing fast-spreading pandemics. The pandemic has caused what is being called a structural shift for digital healthcare in many countries, including India. The current situation prescribes that it is time for India to reboot healthcare and support healthcare startups for closing the gaps in the traditional healthcare system.
The pandemic has put a spotlight on the vibrant healthtech ecosystem and provided a new opportunity to revisit the cycle of patient’s clinical assessment, treatment, and monitoring. The integration of healthcare with technology is blurring the divide and improving patient care services, increasing access, affordability, and lowering costs. The pandemic is accelerating the use of technology to radically advance medicine and save lives. It is allowing the digital health community to leverage the incredible progress over the past several years in fields such as big data analytics, artificial intelligence, remote learning, and data interconnectivity. India, despite its infrastructure and immense population, is doing its best to fight the ongoing virus through different information campaigns.
In India, the health-tech market can be broadly divided into six segments –
It is the practice of medicine using technology to deliver healthcare services remotely. Through this, a registered physician at one location can use telecommunications infrastructure to deliver care to a patient at a distant location.
It is a one-stop online marketplace where a patient can order prescription drugs, OTC (Over The Counter) health products and gets them delivered to their doorstep.
Fitness & wellness
Online fitness and wellness services and products being provided by various means. The products include a vast variety such as gym, yoga, group workout, physical & mental health counseling, diet consultation, nutritional food supplements, healthcare products among others.
Healthcare IT & analytics
Healthcare organizations may use SaaS (Software as a Service) and other Cloud solutions to manage and access resources, patient records, data, and healthcare infrastructure.
At-home healthcare services for patients and the elderly.
Personal health management
Health advisory content aggregators, and personal health tracking apps, wearables, and monitoring sensors.
Healthtech startups in India
Startups in India are slowly redefining the delivery of quality healthcare in India, bridging the gap between patients and healthcare providers through various digital solutions. It does not just bridge the gap but also creates an ecosystem designed to deliver better and faster quality healthcare within the environment. There are about 3,225 startups in India that focus on healthtech and various others are setting up. The main focus of most startups is to help access healthcare resources. This is not a surprise because the ratio of medical specialists to patients is quite imbalanced in the country. The Government of India also leveraged the potential of digital healthcare with the Aarogya Setu app, to help people self-assess themselves for coronavirus.
Due to the rise of healthcare startups in India, we will soon be looking at the benefits of genomics, biotech, and robotics in hospitals and clinics to improve the efficiency of healthcare services. Artificial intelligence can accurately diagnose illnesses, while applications that track our vital signs and movements can improve the country’s overall health.
The major line of healthtech startups that have reached the market peak are listed below:
Segment: Healthcare IT & Analytics
Innovaccer is a provider of an AI-based patient health data analytics platform. The product is used in healthcare centres for population health management. The company has developed a data activation cloud-based platform to collect, analyze, and provide insights on patient health. The company’s offerings are InNote, InConnect, InGraph, and InCare.
PharmEasy is an online platform provider for ordering medicines and diagnostic tests. It offers a smartphone app for ordering medicines from a local pharmacy and home sample collection for diagnostic testing from nearby labs. Users can upload the picture of their prescription and place orders with the local pharmacy. It also enables users to search and book diagnostic tests with home samples collection. The platform can be used for buying other healthcare products and supplements too.
1mg is a provider of an online pharmacy marketplace with doctor listing and teleconsultation services. It offers an online pharmacy store where the user can view medicines, compare prices, and purchase online. The user can also upload prescriptions for placing the order. It also offers an online doctor consultation platform that allows users to search for doctors and book appointments. The platform also sells fitness supplements, healthcare products, healthcare devices, and alternative medicines.
Segment: Fitness & wellness
Curefit is an integrated fitness training and nutrition coaching platform. It is offering a chain of fitness centres for dance, yoga, and workout under the brand CureFit for training at the gym and home. It also provides an online mental wellness platform under the brand MindFit and a healthy food delivery platform under the brand EatFit that provides healthy meals, snacks, and beverages.
Practo offers an online platform for appointment booking, telemedicine, and practice management. It offers a web-based platform that benefits both patients and doctors. It enables patients to browse through doctor profiles online, book confirmed appointments, and get chat-based teleconsultation.
Segment : Telemedicine
Mfine is a mobile application provider for an online doctor consultation, appointment booking, and medicine delivery. It facilitates online consultation with doctors from nearby hospitals. Featured specialties include pediatrics, gynecology & obstetrics, and general medicine. It also offers home services like examination and sample collection for lab tests.
MediBuddy is a provider of mobile app for online doctor consultation with other services. It provides an online platform where users can search for healthcare providers and can communicate with them for their treatments. It allows users to purchase healthcare packages, schedule appointments with doctors, order medicines for door delivery, and access their digital medical records. It also enables users to send pre-authorization requests and claims intimation in case of hospitalization.
The legal and regulatory framework in the sector
The Information Technology Act, 2000, and the Information Technology Rules, 2011
The regulations also require the use of appropriate security measures while processing data. If the body corporate complies with the international standard “Information Technology – Security Techniques – Information Security Management System – Requirements” or equivalent standards authorised and declared by the Central Government, this criterion is met.
No such guidelines have been announced as of yet. Appointing a ‘Grievance Officer,’ whose contact information must be disclosed on the internet, is also required. There are also other considerations, such as allowing users to withdraw or change their SPDI if necessary.
The IT Act, 2000 does not apply to digital health services that have setups that only enable the connection between the patient and the service provider and are not directly involved in the supply of services, such as website hosting services and search engines. In such circumstances, the service provider would be classified as an intermediary under the Intermediary Guidelines and the IT Act, and intermediaries are granted specific exemptions from liability for third-party data or communications. Under the IT Act, an intermediary is not liable for third-party content hosted by the intermediary if the intermediary’s role is limited to providing access to a communication system over which information is hosted or stored, and the intermediary has followed the due diligence requirements outlined in the IT Act.
The constitutionality of the Intermediary Guidelines and Section 79 of the IT Act was challenged before the Supreme Court in the case of Shreya Singhal v. Union of India (2015), stating that these provisions were vague, broad, and in violation of Article 19 of the Constitution of India, which provides for the fundamental right to the freedom of speech and expression.
It was claimed that Section 79 and the Intermediary Guidelines provide the intermediary freedom in deciding whether or not to publish unlawful or offensive information, and that the constraints imposed by the Intermediary Rules go beyond the limitations imposed by Article 19(2). The Supreme Court interpreted Section 79 of the Act and the Intermediary Guidelines to indicate that the intermediary must receive a court order or communication from a government agency ordering it to remove the particular content. The court further noted that any such court order or notice must fit within the scope of Article 19(2)’s reasonable limitations, implying that any removal must be legal.
Other Service Providers Regulations under the New Telecom Policy 1999 (“OSP Regulations”)
Service providers who provide “Application Services” – such as telemedicine – utilising telecom resources provided by telecom service providers must register with the Department of Telecommunications as an “Other Service Provider” (“OSP”). There are various startup legal service providers that can help new startups with all such legalities.
The Drugs and Cosmetics Act, 1940 (“D&C Act”) and Drugs and Cosmetics Rules, 1945 (“D&C Rules”)
The D&C Act , 1940 and D&C Rules, 1945 regulate the manufacturing, sale, import, and distribution of drugs in India. In many foreign jurisdictions, there is a clear distinction between a drug that must be sold under the supervision of a registered pharmacist on the production of a valid prescription and those that can be sold by general retailers over-the-counter (“OTC”). OTC drugs have a different meaning in the context of Indian laws.
The D&C Act requires that all drugs must be sold under a license. The D&C Rules lay down which drugs can be sold only on the production of a prescription issued by a registered doctor, which implies that there is a distinction between prescription and non-prescription drugs. The D&C Act states that no person can sell any drug without a license issued by the licensing authority. However, it provides for certain drugs, namely those falling under Schedule K of the D&C Rules, to be sold by persons who do not have such a license.
As a result, in the Indian context, OTC medications would only refer to medicines listed under Schedule K. These include, among other things, non-prescription medicines, quinine and other antimalarial treatments, magnesium sulphate, chemicals meant to kill rodents or insects that cause sickness in humans or animals, and domestic cures.
The Indian Medical Council Act, 1956 (“MCI Act”) and The Indian Medical Council Regulations, 2002 (“MCI Code”)
The MCI Act , 1956 administered and enforced by the Medical Council of India, regulates the medical education and medical profession in India. Only individuals having a recognised medical degree and registration with one of the state medical councils are allowed to practice medicine in India, according to the MCI Act. The MCI Code, 2002 establishes professional and ethical guidelines for doctors in their interactions with patients, pharmaceutical firms, and colleagues.
The MCI Code also specifies that efforts are to be made to computerized medical records so that they can be retrieved quickly. The MCI Code binds doctors and requires them to sign a declaration to that effect. The MCI Act is currently in the process of being repealed and replaced by the National Medical Commission Act, 2019 (“NMC Act”). Provisions of the NMC Act establishing the National Medical Council (the apex regulatory body to replace the Medical Council of India) and other advisory councils have already come into force while remaining provisions are expected to come into force soon.
Telemedicine Practice Guidelines
The Board of Governors instituted by the Central Government for regulating medical education and the medical profession in India (in supersession of the Medical Council of India), issued the Telemedicine Practice Guidelines in partnership with the NITI Aayog. These principles have been included in the MCI Code and are therefore binding on allopathic medical practitioners. The Telemedicine Practice Guidelines allow medical practitioners to practice telemedicine from anywhere in the country, and they advise on the types of treatment that can be provided and how they should be delivered. The Guidelines also divide medications into four categories: List O, List A, List B, and Prohibited List, indicating which medicines can be administered in which circumstances. On the other hand, the Telemedicine Practice Guidelines are just a stopgap solution put in place owing to the COVID-19 pandemic’s necessities until a more complete regulation can be put in place.
To properly regulate the practice of telemedicine, the Indian Government may consider enacting comprehensive legislation regulating telemedicine that is binding not only on the healthcare practitioner providing consultation by way of telemedicine but also on the platform provided.
The Drugs and Magic Remedies Act, 1954 and Drugs and Magic Remedies Rules, 1955 (“DMRA”)
The DMRA was enacted in 1954 to curb advertisements of drugs and remedies alleged to possess magic qualities. The DMRA prohibits persons from taking part in the publication of an advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for—
- the procurement of miscarriage in women or prevention of conception in women; or
- the maintenance or improvement of the capacity of human beings for sexual pleasure; or
- the correction of menstrual disorder in women; or
- the diagnosis, cure, mitigation, treatment, or prevention of any disease, disorder, or condition specified in the schedule to the DMRA.
Advertisements may, however, be delivered privately to registered medical practitioners and chemists, as long as the words ‘For the use exclusively of registered medical practitioners, a hospital, or a laboratory’ are added in indelible ink and prominently displayed at the top of the paper.
The Ministry of Health and Family Welfare, on February 03, 2020, published a draft amendment to the DMRA to amend the definition of ‘advertisement’ under the DMRA to specifically include advertisements made over an online-only electronic medium, increase penalties for violation of the DMRA and expand the list of diseases, disorders or conditions in the schedule to the DMRA. However, the proposed amendment does not substantially alter the existing regulation as advertisements over electronic media were already within the purview of the DMRA.
Telecom Commercial Communication Customer Preference Regulations, 2018 (“TCCP Regulations”)
Sending unsolicited commercial communication over voice or SMS is prohibited under the TCCP Regulations. Only customers who have opted in to receive promotional messages after registering with an access provider may get them. Sending transactional messages or making phone calls, on the other hand, is not prohibited by law. A transactional message is triggered by a transaction carried out by the message’s recipient, as long as the recipient is a customer of the sender and the message is delivered within 30 minutes after the transaction and is directly connected to it. Any information transmitted for an OTP or the purchase of goods and services, for example, would be considered a transactional message. All other messages (even those directly related to the delivery of products) must be delivered using a format that has been registered with the access provider and only with the receiver’s approval.
The Clinical Establishments Act, 2010 (“Clinical Establishments Act”)
Establishments falling under the definition of a ‘clinical establishment’ under the Clinical Establishments Act, 2010 would be required to register with the relevant authority and conform to the minimum standards as prescribed under the act. Except for the National Capital Territory of Delhi, the Clinical Establishments Act applies in Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, Bihar, Rajasthan, Uttar Pradesh, Uttarakhand, Jharkhand, Assam, Haryana, and all Union Territories. Maharashtra and Karnataka, for example, have their own state clinical establishment legislation.
Future of healthtech sector
Business and technology will be mutually driving each other in the future as the ecosystem grows; digiceuticals or digital treatments are an example of the latter. Another noteworthy development in the business is the transition away from treatment-specific approaches and toward therapeutic and holistic approaches. As medicine becomes more customised, the creative use of artificial intelligence and machine learning will result in non-invasive, digital diagnostic and treatment options. The following are some of the sector’s rising technologies and trends:
Cloud infrastructure in healthcare record maintenance
Increased focus on digitalisation of patient healthcare records is likely to accelerate further. Cloud Infrastructure and mobilisation of data to the cloud are crucial factors in achieving digitalisation by establishing a common public database for patient healthcare records which will facilitate opportunities for related healthcare products and services.
Wider application of robotics
The application of robotics is growing rapidly in the healthcare and medical industry and going forward wider application of ‘humanless’ systems and technology is expected especially in surgery, prosthetics, therapeutics, healthcare logistics, pharma manufacturing, etc. Robotics provides numerous benefits such as precision, sophistication, minimally invasive surgery, etc. Innovation and technological advancement and cost efficiency are likely to drive further use of robotics.
3D bioprinting applications
Though 3D bioprinting is at a very nascent stage in India, increased adoption of 3D bioprinting will provide opportunities for existing healthtech startups and new entrepreneurs. 3D Bioprinting finds its application in drug testing, living human tissue production, medical research, and development.
The Internet of Medical Things (IoMT)
The Internet of Things in conjunction with telemedicine has created a new Internet of Medical Things (IoMT) which has come to play a critical role in monitoring and preventing illnesses. IoMT is an internet-connected ecosystem of medical devices and equipment, data applications, health IT systems, and healthcare services. Its applications in wearables such as ECG, blood pressure, and blood sugar monitors connected with smartphones and online patient data records are likely to have a transformational impact on preventive healthcare.
Machine learning and artificial intelligence
healthtech startups are betting big on AI and Machine Learning for their immense potential in Clinical Data Analytics, Neurology, Radiology, Diagnostic Analytics, etc. AI is increasingly becoming a transformational force bringing intelligence to medical equipment and devices, having far-reaching implications on human-machine interaction. AI-driven analytics, tools, and machines can help healthcare providers find the right approach for each patient with more efficient, precise, and impactful interventions.
Nanomedicine: application of nanotechnology
Nanomedicine, like robotics, is a rapidly developing field in healthcare with enormous potential. Nanomedicine is the use of engineered nanodevices and nanostructures in medicine for the diagnosis, control, treatment, monitoring, and prevention of diseases. Nanotechnologies are being studied for use in illness diagnostics, medication delivery to particular body locations, and molecular imaging, with many devices now undergoing clinical trials.
Changing consumer needs and preferences
As consumers have become more tech-savvy with increased usage of the internet and smartphones, healthcare has also evolved to cater to ever-changing consumer needs and preferences. Healthtech is transforming the way healthcare is supporting patients in their day-to-day lives encompassing social determinants of health such as inequalities, income disparity, varying education levels, place of residence, transportation system, accessibility to resources and healthcare facilities, etc.
Emergence of Paratelemedicine
The success of telemedicine in connecting patients with doctors has led to a possibility for hospitals to connect paramedics with specialist doctors for ensuring faster healthcare delivery. Through telemedicine, paramedics will be able to consult doctors remotely and take timely actions to save lives and ensure appropriate treatment.
healthtech to continue to attract investment
Triggered by the COVID-19 pandemic, healthtech is poised for rapid growth and will keep attracting public and private investments. There shall be a further acceleration in fundraising by startups, M&A deals, and IPOs with the evolution of a robust healthtech ecosystem in India.
Augmented Reality & Virtual Reality
The use of Augmented Reality and Virtual Reality in telemedicine can greatly improve the quality of healthcare services to patients. It can also be used in teaching medical students through simulated interventional procedures. Research and studies have shown the possibility of wider applications of these technologies across various streams and workflows.
Increasing use of wearables devices
Wearable devices help in getting real-time patient data which plays a critical role in preventive healthcare. Wearables combined with the Internet of Medical Things (IoMT) platforms and technologies have the potential to change digital healthcare.
Blockchain is another technology that has the promise to greatly enhance the healthcare industry. For example, patients can get their transaction and medical records in a secured manner through the use of digital ledgers. Apart from technologies like IoMT and cloud computing, blockchain can further help to improve the accessibility, security, and portability of healthcare solutions.
The rippling impact of technological improvements is expected to be noticed across the healthcare industry in India as it continues to expand with the underlying technology. Data analytics and predictive healthcare will become more accurate as healthcare data becomes more extensive. This will address the issue of healthcare access, while improved prediction accuracy will boost the personalization element of fitness and wellness goods while also reducing the time it takes to treat patients. Personalised therapy will not only assist in more effectively target diseases, but it will also aid in the development of the biotech, biopharma, and medical device sectors.
The public stands to benefit greatly from the growth of the digital health business in a country where affordable healthcare remains a major concern. With the public interest at the forefront of both regulators’ and innovators’ thoughts, it remains to be seen whether the country’s evolving legal and regulatory framework will stifle or accelerate its progress. While there is still a long way to go, it is anticipated that the industry’s general good perspective and support will continue and sustain itself in the future.
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