At some point in every person's life, you will need an assisted medical device - whether it's your glasses, your contacts, or as you age and you have a hip replacement or a knee replacement or a pacemaker. The prosthetic generation is all around us.
(American athlete who was born with a medical condition that resulted in the amputation of both of her legs beneath the knee)
Early Adoption of MedTech
This is the age of technological revolution, and it is turning the keys for the future in today's world concerning life sciences and healthcare sectors from monitoring of patients through continuous monitoring devices to robotic assisted surgeries. The shift from traditional to analytical decision making has moved the needle in the right directions and the early adoption of these contemporary trends will be highly crucial and of vital importance. The emergence of digital health technologies has fast-tracked the MedTech evolution where newer technologies such as Apple watches, sensors, tracking devices, clinical decision-making tools using artificial intelligence (AI), robotic assisted surgeries, machine learning (ML) algorithms etc. are being used as new standards of care.
The Central Drugs Standard Control Organisation (CDSCO), on February 11, 2020, issued a notification to extend the scope of the devices regulated under the Drugs and Cosmetics Act, 1940 and further included 'software' to be considered as medical devices if it is used for, inter alia, diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder.1 Developed countries such as the United States, Canada and Australia, have defined laws and/or regulations and are in the process to further develop software which will be used for medical devices. Further, many countries have accepted harmonised international guidelines for evaluating and approving softwares and monitoring devices such as blood pressure and heart rate monitors that check the patients' vitals.
The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. Numerous wearable devices such as patches and smart watches now exist that can register vital signs such as respiratory rate, oxygen saturation (SpO2), heart rate and blood pressure. These devices are increasingly accurate, reliable, mobile, and come with user-friendly features which can be seen in use in the day-to-day activities of the general public. This has left two options for the hospitals - either to adopt the new and effective ways to diagnose and monitor patients in their facilities with the latest and approved technologies, or to continue with the status quo of using the prevalent outdated technologies. Early adoption of these technologies will be the key for the future to come, as this is going to be the accepted or 'reasonable standard of care', going forward.
MedTech Industry bridging the gap between Wellness and Patient Care
Developments in medical technology have long been confined to procedural or pharmaceutical advances, while neglecting a most basic and essential component of medicine: patient information management.
(Attorney and an American Politician)
Technology is increasingly influencing and bridging the gap between the patient and their body health status/information. During and post COVID-19, most people have undertaken to monitor their SpO2 levels and other vitals through use of technology that is readily available. There are a multitude of wearable devices which can be used for continuous monitoring of the vitals without being admitted to any healthcare institute and thereby increasing safety and incident-awareness actively.Today's technology is increasingly influencing health care and facilitates patients' mobility and recovery during admission. This helps bridging the gap for use of medical technology devices by the healthcare industry as well as the masses who are now more aware about their health status, closely monitored diet regimes, exercise and rest patterns for the longevity of life.
In healthcare industry, medical technology can result in improved health outcomes and can be used as a diagnostic tool in the identification of several diseases or clinical deterioration during admission. During the wee hours, when fewer medical personnel are available, clinical deterioration may remain undetected until the next morning. However, with improved and new medical technology now available, patients can be monitored more frequently for clinical deterioration and thus, any mishap can be detected at an earlier phase. Any change in vital signs of the patients that are often present 8 - 24 hours before a life-threatening event can be now noticed and adverse incidents can be circumvented and/or avoided. Additional benefits of continuous monitoring devices include reduction in the workload of healthcare professionals and allied work staffs since it would require fewer vital sign measurements and safe patient transport between wards. ICU's have the best quality of patient monitoring, a 1:1 nurse to patient ratio with continuous bedside monitoring. Unfortunately, this only accounts for 5% of the ~2 million hospital beds in India today. The rest of the beds are monitoring with intermittent manual spot checks by nurses.
One of the India's leading MedTech start-ups, Dozee, co-founded by Gaurav Parchani and Mudit Dandwate, is working towards an effective solution for the continuous monitoring systems. Dozee is India's first AI-based contactless remote patient monitoring (RPM) & early warning system (EWS) for continuous patient monitoring with a mission to develop and deploy intelligent technologies, solutions, and networks to provide a continuum of care, early warning systems, and responses to save lives. With contactless continuous remote patient monitoring, Dozee enhances patient safety with real time vitals and early warning systems, at the same time reducing the burden of the time spent in manual spot checks and charting by nurses.
Dozee enables healthcare professionals to remotely monitor patients' vital parameters such as heart rate, respiration rate, blood pressure, SPO2 levels, temperature, and ECG. Dozee's early warning system (EWS) tracks the trends of the vital parameters and provides alerts to healthcare providers for early detection of clinical deterioration of patients enabling timely medical intervention. Dozee uses AI-powered Ballistocardiography (BCG) for contactless vitals monitoring. Dozee's technology is patented and made in India.
Gaurav and Mudit say, "Dozee's innovative technology has a clinically proven accuracy of ~98.4%. By automating patient monitoring through Dozee, nearly 2.5 hours of nursing time is saved every day per patient."
Is medical negligence liability a barrier to adopt MedTech by Healthcare Industry?
In the realm of the healthcare industry, medical negligence liability has played a crucial role in creating apprehensions for the adoption of novel and latest MedTech technologies by healthcare professionals and health-care organisations. Building upon the same, Indian courts have provided a much-needed clarification relating to medical negligence through numerous judicial pronouncements, and we discuss some of them herein below.
In the case ofAchutrao Haribhau Khodwa and Ors. v. State of Maharashtra and Ors,the Supreme Court noted that in the "very nature of medical profession, skills differ from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession."
In Dr. Harish Kumar Khurana v. Joginder Singh and Others (2021), the Supreme Court held that hospital and doctors are required to exercise sufficient care in treating the patients in all circumstances. However, in an unfortunate case death may occur. It will be necessary that sufficient material on medical evidence should be available before the adjudicating authority to arrive at a conclusion that the death is due to medical negligence.
The Supreme Court in Vinod Jain v. Santokba Durlabhji Memorial Hospital referred to the understanding adopted in Hucks v. Cole which reads as follows:
"A medical practitioner was not to be held liable simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference of another. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field."
InSardar Kuldeep Singh v. Escorts Heart Institute and Research Centre, the bone of contention was that the progress note of the patient was not recorded by the hospital staff, among other reasons and this was alleged to constitute negligence. It was said that a proper and timely monitoring could have alerted the doctors about the emergency and prevented a panic reaction on their end prior to the patient being declared dead. To substantiate that the defendants weren't negligent, the accused institute established that they did in-fact monitor the patient and the timely and proper monitoring of the patient's health was evidenced by the medical records, nurse's chart, temperature chart and various other reports maintained by the staff.7 It may be noted that the records of continuous monitoring of the patients were used as part of evidence to prove that the patient's vital status were actually recorded, and a reasonable standard of care was provided to the patient.
Today, basic monitoring equipment are readily available, and we strongly believe that gradually, medical professionals would be expected to use the latest monitoring devices as 'reasonable standard of care' as these monitoring devices are built and based on the latest scientific and technological knowledge available. Moreover, the Sardar Kuldeep Singh case shows how these monitoring devices are in fact an asset to prove absence of negligence. If anything, they can be used to show that healthcare professionals have employed a reasonable standard of care that this era demands. And, if the doctors employ such monitoring devices that have become an acceptable practice to this day and age, they would not be held liable for negligence regardless of other methods are available.
*Link Legal presents 'MedTech Law Event', engulfing series of focused articles and webinars on the MedTech Industry and its impact on the healthcare delivery. Join Link Legal on Tuesday, 14 March 2023 for the webinar on "MedTech Impact on Healthcare Industry".
To know more and register for the webinar, click here.
1.CDSCO Notification dated February 11, 2020, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA==.
2. Achutrao Haribhau Khodwa and Ors. v. State of Maharashtra and Ors., (1996) 2 SCC 634.
3. Dr. Harish Kumar Khurana v Joginder Singh and Others, Civil Appeal No. 7380 of 2009, Supreme Court of India, decided on September 7, 2021.
4. Vinod Jain v. Santokba Durlabhji Memorial Hospital, (2019) 12 SCC 229.
5. Hucks v. Cole, (1968) 118 New LJ 469.
6. Sardar Kuldeep Singh v. Escorts Heart Institute & Research Centre, (2015) NCDRC 3943.
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