"We didn't stay in the caves. We haven't stayed on the planet. With biotechnology, gene sequencing, we are not going to even stay within the limitations of biology".
-Jason Silva
INTRODUCTION
We live in the 21st century, where everyone is dependent on technology and the digital world; and with this increasing pace of technology, one of the most significant industries, the healthcare industry, is rapidly adapting to the technology known as Digital health. Technology is advancing and has reformed multiple facets of the healthcare industry, be it patients' online consultancy, self-monitoring health devices, or cross border robot-assisted surgeries. With all these inventions and advancements, the law comes into the picture, particularly when the question of liability arises; when things go out of the track, there arises a possibility of something wrong happening. This is the time when questions like "Who should be blamed- the digital device or the doctor who is using it" are put forth. For example, in October 2017, many patients in the UK sued the manufacturer for manufacturing allegedly "defective" and faulty hip replacements. ‘Pinnacle Ultamet’ is one of the largest product-liability group actions in the country, which pertains to the claim of their clients, who are affected by the release of metal particles from implants, which can damage the surrounding tissues and cause symptoms such as pain and swelling. Though, the Court gave the verdict against the patients’ claim, after determining that they "did not suffer any adverse reaction to metal debris"[1], such cases against manufacturers are relatively common and liability in the digital era is emerging as an area with serious complex problems.
LIABILITIES EMERGING OUT OF LEGAL BREACH
Liabilities can be both, civil or criminal, depending upon who is being sued, either the service providing doctor or the product providing company. Liabilities which could arise are:-
1. Civil Suits: - Civil suits could arise due to negligence on the part of a service provider while rendering the service or due to breach of the legal obligation between the Digital health device, the provider, and the user/patient. There is a fiduciary relationship between doctor and patient and the same is the situation when a doctor provides health-services through digital means. As per the Supreme Court of India, a “person who gives medical advice or treatment impliedly has possessed skill and knowledge for the purpose, such person owes certain duties, viz., a duty of care in deciding whether to undertake the case, in deciding what treatment to give and in administration of that treatment". A breach of any of these duties shall bring a suit of negligence against the doctor[2]. These liabilities could also arise due to some technical fault in the devices used by doctors or hospitals in these situations. A patient can't sue the product companies, it is the doctor who can be sued and can be held responsible in cases of negligence[3], but the increase in digital health services has put forth a question of who should be sued and for what negligence should a product company be sued, which is still an unanswered question.
2. Liabilities under The Consumer Protection Act, 2019:- Consumer Protection Act, allows consumers to claim compensation against deficiency of services, defective products, and unfair practices. As per the Consumer Protection Act 2019, the health care system has been excluded and the medical society is appeased by this law[4], if we look into it carefully, still there is a vast scope of filing cases against deficiency in health care. The important question is if a doctor remains deficient in providing the service, can he exonerate from the prescribed liability. Although the Consumer Protection Act excluded healthcare from the definition of service, we should not forget the view of the Supreme Court, in the landmark judgment[5], wherein it explicitly included medical services in the ambit of the said Act. Medical service here includes digital healthcare provided by various specialized doctors as well as medicinal product manufacturers.
What will happen if the production and manufacturing company was at fault? Would the doctor still be held liable? - This is yet to be resolved.
3. Criminal Liability: - Criminal prosecution in cases of medical negligence only takes place when the negligence is extremely gross. Since we are talking about digital health, accusing the doctors is not entirely fair. Today, 76% of healthcare providers are using digital recorders for their work[6]. So, making only doctors liable today is not a fair call as more than half of the healthcare of the world depends upon digital devices and services. The principle of vicarious liability is not applicable in the cases of criminal prosecution, which means an online platform that provides digital health services will not be held liable for the acts of its employees, through which they have escaped their liabilities causing serious concern.
ARE EXISTING LIABILITIES ENOUGH FOR INCREASING DIGITALIZATION
Administration of healthcare via digital platforms is increasing day by day; there are approximately 4892 start-ups in India health-tech space[7] and Health-tech start-ups in India have raised a total of US$ 504 million from 2014-2018[8]. With this rapid increase in technology, a lot of problems arise. Earlier, when a particular patient got a treatment from a particular doctor and if something went wrong, that doctor was liable for that. But, due to such an intrinsic and complex structure of digital health, it is hard to decide who is at fault and who should be held liable. Today, if a particular device is flawed, it can harm a large number of people, and it will be tedious to blame anyone because of the complex technicalities, while the damage is extensive if one used the device wrongfully or of a flawed device. It would be hard to determine why harm has occurred and who should be held responsible for the same. This is a serious concern with issues like health care attached to well-being and life because any flaw in artificial intelligence, other than healthcare could still be rectified. This issue needs proper analysis and solutions. Technology is rapidly developing and will continue to develop further. One does not have the option of hiding behind the walls of artificial intelligence so as to mask his own fallacies.
CONCLUSION
The digital health market provides an opening to a lot of professions, but with every opportunity, arises the possibility of a risk. Thus, it is said by Barry Steinhardt that "Technology is outpacing the law" as the advancements in this sector are still immature. Therefore, Law and regulations are a few steps behind. Unless the question of liability is answered, we are risking many lives at the stake of technology involving digital health. The makers of law and the Courts have to come up with better legislation as a solution so that the harm could be prevented. Concerning digital health, the laws of our country should be modified to maintain pace with technology and to regulate the procedures. Otherwise, the digital advancements in healthcare would be of little use without a proper system of providing moral as well as legal justice.
[1]"Hip implant patients sue manufacturer", BCC News,(16th October 2017),https://www.bbc.com/news/health-41634354 [2]Laxman Balkrishna Joshi v. Trimbak Bapu Godbole and Anr. 1969 SCR (1) 206 [3]Jacob Mathew v. State of Punjab & Anr. (2005) 6 SCC 1 [4]Schwartz R, Furrow BR, Johnson SH, Stoltzfus Jost T, Greaney TL. Bioethics: Health Case Law and Ethics. West (Thomson Reuters): American Casebook Series; 1991:624. [5]Indian Medical Association v. V. P. Shantha and Ors [6]Informa Markets,Topline digital health stats for India,Digital Healthcare in India “Healthcare of the Future”,(September 2020),https://www.indiahealth-exhibition.com/content/dam/Informa/indiahealth-exhibition/en/downloads/Digital%20health%20report%202020.pdf. [7]Informa Markets,Topline digital health stats for India,Digital Healthcare in India “Healthcare of the Future”, (September 2020),https://www.indiahealth-exhibition.com/content/dam/Informa/indiahealth-exhibition/en/downloads/Digital%20health%20report%202020.pdf. [8]ibid.
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