DIGITAL HEALTHCARE: ILLIMITABLE AVENUES AND INESCAPABLE CHALLENGES
This piece has been authored by Tanuj Agarwal, a third year student of B.Com.LL.B.(Hons.) at the Institute of Law Nirma University, Ahmedabad.
1. Introduction to Digital Healthcare
Digital healthcare means merging of digital technologies with health and well-being to advance the proficiency in delivering medical services by developing precise and personalized digital treatment. The government’s initiative of Digital India have enticed numerous digital healthcare start-ups (hereinafter “Start-ups”). These Start-ups are bringing digital healthcare technologies such as:
a) Telemedicine: It provides clinical healthcare services over telecommunication set-up through consultation and examination over conferencing without any in-personal visit. It is mostly used for treatments which required frequent follow-up consultation and medication management.[i]
b) Tele-healthcare: It has broader scope as it includes clinical as well as non-clinical services. Apart from remote examination, it also provides non-clinical services such as providing training, administrative work, biomedical technology.[ii]
c) Telecare: It assist patients to manage their health independently by incorporating sensors which connect them to caregivers & give medical alerts, health emergency warnings, exercise tracking, etc.[iii]
d) mhealth: It means mobile health. Unlike other technologies it exclusively works on mobile devices. It majorly includes medical and fitness apps which collect & track health data to manage health.[iv]
2. Emergence of digital healthcare industry and its economic significance
Providing accessible, affordable and excellent healthcare services to such a vast population are the key challenges confronted by Indian healthcare industry. Indian healthcare industry has attained great expansion in rendering services to its patients. However, it has not yet covered substantial population in rural areas. Even if urban areas have quality medical institutions, they are unable to work efficiently because such institutions are flooded with patients that cause inconveniences and time constrains. In India, there is requirement of additional 6-7 lakhs beds for the upcoming 5 to 6 years that calls for an investment of $30 billion.[v] Consequently, the emergence of digital healthcare can provide for such additional spaces required in near future and offers a worthy investment avenue. The overall healthcare market in India is valued at $100 billion and is likely to cross $372 billion by 2022.[vi] Precisely, digital healthcare sector is expected to reach at $9.60 billion by 2022.[vii]
As per the review conducted by Assocham, Indian telemedicine market is increasing at a compounded annual growth rate (CAGR) of 20% and is expected to reach $32 million mark by 2020.[viii] Furthermore, within digital healthcare, mHealth is one of the biggest sectors which is anticipated to cross $1 billion by 2020. Such a momentum in digital healthcare indeed provides a window to invest in technological-based medical solutions that carries affordability and quality, and thereby imparts a significant contribution to Indian economy.
3. Advantages of digital healthcare
1. Mobility is the biggest advantage of digitization. Digital healthcare provides medical services to patients who are physically constrained but require hospital based care. Chronic patients require continuous examination by doctor, but they are usually not in a condition to do so. Technology based treatment gives assistance to such patients for their unremitting treatment. Such service can also be used for post-acute rehabilitation and for cancer patients who are terminally ill.
2. There are some disease such as mental health, HIV, etc. which usually get untreated because there are social taboos attached with them. Digital solution makes it simpler for such patients to pursue treatment in a secret and anonymous manner.
3. Digital healthcare also extent to spectrums such as diagnosis, monitoring and management services. For example, it facilitates to design, monitor and recommend personalized diet and exercising plan by collecting and diagnosing personal health information.
4. It also helps in administration by providing better internal communication among staff and seamless transmission of information. Clinical system based on SaaS (Software as a Service)[ix] can be used for real-time management of patients, delivery of medicine, facilitating consultation, etc.
4. Challenges in digitization of healthcare
Digitization of healthcare immensely modified the healthcare industry and offers numerous benefits to all the stakeholders. Healthcare providers should look to the future and embrace such change. However, there are certain issues which necessarily be looked upon while stepping towards digital healthcare.
1. Privacy and security of patients’ data stored in digital form: Healthcare providers are underway to maintain electronic medical records. Digitization of healthcare provides the way for advanced health information system to increase accessibility and availability of patient data which helps in reducing medical errors.[x] Since the advent digital healthcare provides for storing of patient information on large scale, there is a necessity to ensure confidentiality and security of such information. For that purpose, Ministry of Health and Family welfare has recommended to set up a National e-Health Authority (NeHA), through an Act of parliament.[xi] NeHA seeks to regulate the collection, storage, access, exchange and use of patient data stored in digital form such as age of patient, clinical description, medical history, contact details, various medical reports, sensitivities, medication, etc. Currently, India does not have any dedicated data protection law.
However, Indian Supreme Court in the case of Justice K.S. Puttaswamy (Retd) v. Union of India recognized Right to Privacy in light of Article 21 of Indian Constitution.[xii] National Digital Health Blueprint also emphasized on “ensuring the security, confidentiality and privacy of health-related personal information”.[xiii] Moreover, India is also in progress to form a dedicated regime for personal data protection. Justice BN Srikrishna committee proposed the draft “Personal Data Protection Bill, 2018” which would necessarily have to be complied by digital healthcare industry when it would translate into law.
2. Liability of incorrect treatment because of technical glitch: In India, the regulations pertaining to medical negligence impose both civil as well as criminal liability on medical practitioners.[xiv] Medical Practitioners are criminally liable under section 304A of Indian Penal Code, 1860 which impose liability on a person who causes death by rash & negligent act not amounting to culpable homicide.[xv] Medical services also comes within the ambit of “services” under section 2 (1) (0) of the Consumer Protection Act, 1986, thereby doctors can be held liable in case of any deficiency in services.[xvi] There doctors are also liable in Tort law in case of breach of duty of care.
However, it is relevant to note here that Indian medical negligence regulations do not distinguish the cases in which there is a negligence on part of doctor or such negligence is caused because of some technical glitch, since the major focus of regulations is on commission of rash and negligent act. Presently, the doctors cannot take the defence that he has relied on recommendations of digital health solutions for prescribing incorrect drugs. Thereby, digital healthcare imposes an additional legal liability where negligence in diagnosis caused by malfunctioning of technology.
3. IPR protection to digital healthcare solutions: Developing digital healthcare solutions based on artificial intelligence (AI) needs a substantial amount of investment. Nonetheless, the Indian IPR regime is not adequate to protect AI solutions. Under the Patents Act, 1970, algorithms, the basis of developing AI solutions, are not patentable.[xvii] Also, the authorship of work created by AI is still skeptical under Indian Copyright regime as the current scenario only recognize the human-authors of creative work.[xviii] Consequently, there is no IP protection given to startups for developing digital solutions which costs such an extensive amount. Such an approach is a discouragement for startups. With the advent of digitization in healthcare, the traditional approach in IP regime needs appropriate modifications to make it in conformity with technological developments which are defining the future of healthcare industry.
4. Developing comprehensive clinical solution in a digital form: With the advent of digitization in healthcare industry, start-ups require a multidisciplinary approach to create a clinical core.[xix] A well diverse team needs to be developed which comprises medical as well as technological professionals. Before developing technology-based solutions, the major task is to recognize medical intricacies of maladies. Every patient has a specific disorder and thereby requires a correct intervention into that patient pathway. Hence, it creates a challenge to develop an accurate treatment for varieties of patients into a single digital solution which covers each and every case of particular diseases.
5. Developing low-cost digital solutions for greater market coverage: Adopting digital healthcare is worth to the extent that it maintains a balance between quality of treatment and its affordability. Digital healthcare start-ups are expected to satisfy the increasing demand from patients by including service providers who are not yet exposed to digitization.[xx] Unlike large-scale hospital chains which have organizational level digital setup, sole medical practitioner would require low-cost digital clinical solution. Thereby, start-ups need to emphasis on inventing at agreeable price point. Moreover, start-ups have to assure the stakeholders that such digital solution is able to recompense their expenses and will render continuing commercial benefit. Hence, inclusion of large as well as small stakeholders in the digitization of healthcare would not only suffice the mounting demand of patients but also contributes to the economy as a whole.
6. Digital solutions for cases requiring extensive personal checkup: There are certain medical branches such as pediatrics, neurology, dermatology, radiology, orthopedics, etc. which require medical practitioner to examine the patient closely. These branches can be an obstacle for the digitization of healthcare since the technology cannot entirely replace the tactile and in-person checkup by medical practitioner.[xxi] Thereby, the task of the digital healthcare industry is to comprehensively look into such branches and deliberate upon developing their digital solutions.
Despite the numerous challenges, digital healthcare start-ups are an inevitable emerging trend in the digital economy and have also delivered howling early success. Now, these start-ups have the duty to overcome prevailing challenges and scale-up comprehensive digital solutions in healthcare industry. Such an approach will help in attaining better medical outcomes and create more value for all stakeholders in the healthcare economy.
[i] Lawrence Eron, Telemedicine: The Future of Outpatient Therapy?, 51 Clinical Infectious Diseases 224, 225 (2010).
[ii] Susannah McLean et al., Telehealthcare for Long Term Conditions, 342 British Medical Journal 374, 374 (2011).
[iv] Kevin Khachatryan, Medical Device Regulation in the Information Age: A Mobile Health Perspective, 55 Jurimetrics 477, 477 (2015).
[v] Digital health market in India over the next ten years, Science Service: Dr. Hempel Digital Health Network (Oct. 18, 2018), https://www.dr-hempel-network.com/growth-of-digital-health-market/digital-health-market-in-india/.
[vi] Healthcare Industry in India, India Brand Equity Foundation (Mar. 2019), https://www.ibef.org/industry/healthcare-india.aspx.
[vii] Healthcare, India Brand Equity Foundation (Jan., 2019), https://www.ibef.org/download/healthcare-jan-2019.pdf.
[viii] Vinod Kumar Reddy, The boom in digital healthcare is India's opportunity to build global telemedicine companies, Yourstory (Jan. 27, 2018), https://yourstory.com/2018/01/boom-digital-healthcare-indias-opportunity-build-global-telemedicine-companies.
[ix] Software as a service (SaaS) is a model in which service renderer host the application at data center which can be accessed in real-time by customers through standard web browser. In SaaS, updates are automatically implemented without customer intervention.
[x] Harnessing the Power of Data in Health, Stanford Medicine (June, 2017), https://med.stanford.edu/content/dam/sm/sm-news/documents/StanfordMedicineHealthTrendsWhitePaper2017.pdf.
[xi] National eHealth Authority (NeHA), National Health Portal India (June 15, 2017), https://www.nhp.gov.in/national_eHealth_authority_neha_mtl.
[xii] Justice K.S.Puttaswamy(Retd) vs Union Of India, Writ Petition (Civil) No. 494 OF 2012.
[xiii] Ministry of Health and Family Welfare, National Digital Health Blueprint, https://mohfw.gov.in/sites/default/files/National_Digital_Health_Blueprint_Report_comments_invited.pdf(2019).
[xiv] K K S R Murthy, Medical Negligence and the law, 4 Indian Journal of Medical Ethics 116 (2007).
[xv] Indian Penal Code, 1860, Act No. 45 of 1860 § 304A.
[xvi] Indian Medical Association v. V P Shantha, AIR 1996 SC 550.
[xvii] The Patents Act, 1970, Act No. 39 of 1970 § 3(k).
[xviii] Sonil Singhania & Sana Singh, Redefine Intellectual Property with Artificial Intelligence, https://singhania.in/artificial-intelligence-and-intellectual-property-laws-monkey-selfie-copyright-dispute-a-machine-be-an-author-or-an-inventor-innovations-generated-by-ai/ (Sep. 4, 2018).
[xix] John H. Sinard et at., Custom software development for use in a clinical laboratory, 44 J Pathol Inform (2012).
[xx] Florian Rinsche, The Role of Digital Health Care Startups, Crossing Borders-Innovation in the U.S. Health Care Startups 190 (2017).
[xxi] Future Customer, https://www.future-customer.com/digitalization-in-the-health-care-sector-will-computers-soon-replace-doctors/ (Aug. 13, 2018).