SaMD - Need for Regulation
Introduction The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways - from simple wearable devices to complex invasive devices; simple AI software which can predict and sense to complex AI software which can diagnose; sensors and other hardware devices including the mobile phone with ever-increasing computing power. Some of these have made human lives so dependable on these devices, gadgets, software and in some cases, these are dumbing human intelligence. We witnessed software wherein by looking at a camera on the mobile phone, the software can predict the heart rate and many other vitals. What if human intelligence gave way in believing the reading as true? The software or the camera is not a medical device and hence outside the purview of regulations usually applicable for medical devices. Can we ignore the risks? If so, should software be treated as a medical device? Software as Medical Device (SaMD) A broadly accepted definition of a SaMD is the one issued by the International Medical Devices Regulation Forum (“IMDRF”), currently, Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the United States of America are member countries to this Forum. This definition has been adopted by the Food and Drugs Administration (FDA) in the United States, The Medical Device Directive adopted in the European Union in 2010, and in major countries such as Australia, Canada and Japan. The term “Software as a Medical Device” is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. It includes an in vitro diagnostic medical device. It must be capable or running on a computer platform that is not of a medical purpose, and should not need a hardware medical device to achieve its purpose. It can be interfaced or used in a combination with other devices, but cannot be used to drive a hardware device. Mobile applications meeting this definition are also considered as SaMDs.  The ‘medical purpose’ that it must intend to serve can be diagnostic, preventive, investigative, life-sustaining, for treatment of disease or injury, disinfection, control of conception or purely informative. In some jurisdictions, aids for persons with disabilities, devices for assisted reproduction and devices incorporating animal and/or human tissues are also recognized. A SaMD can also be a means to suggest mitigation of a disease or provide aid to diagnosis.  There are further guidelines on the definition of changes to SaMDs- they can be adaptive, corrective or preventive in nature. The manufacturer of SaMD would be a natural or legal person who has the intention for the software to be used under his/its name. It would not include a distributor or the manufacturer of an accessory. The final legal responsibility lies with the manufacturer unless it is specifically imposed on another party by the country’s regulatory authority.  Putting them to use SaMDs are now available in abundance in the Indian market. Both foreign manufacturers, as well as Indian manufacturers, are introducing so many forms of SaMDs. This includes use of artificial intelligence, IoT, general software etc. Interesting, many SaMDs are enjoying high adoption rates not only by early users but continued users. The glaring point is that there is no legislative framework or guidance policy which works as a guiding principle for the SaMD manufacturers or at least as a self-regulating piece of legislation, in India. The Medical Devices Rules, 2017 which will come into effect from January 1, 2018, has now defined medical devices and has made a clear distinction between drugs and medical devices, but still this definition does not include SaMDs or software as a medical device. Interestingly, the draft Medical Devices Rules, 2016 on basis of which the Medical Devices Rules, 2017 have been formalized included software in the definition of medical device. With the market being flooded with AI, IoT, general software, wearable, and wellness and customized medical devices, software as a medical device as a whole should be considered with equal importance in the sector. Curiously, the definition of medical devices under Foreign Direct Investment policy includes software. REGULATIONS The IMDRF has worked extensively in setting guiding principles for governing SaMD and has put in place a regulatory structure for how the SaMDs shall be governed, regulated, clinically evaluated and how the data shall be evaluated and then used by the SaMD. While India has not yet included any software or apps in its regulation purview, countries like USA, Singapore, Australia, EU and Japan has issued guidance documents to make the app developers aware of what might be subjected to regulation. The common theme that determines the classification is the level of risk that these apps pose to the consumers. For example, let’s take an app which allows a user to take ECG test by putting their fingers on an external device which is connected wirelessly to the smartphone. It checks the electrical activity of the heart. Such apps may be considered as risk and be subject to regulation since the belief is that any incorrect analysis may hamper a user’s treatment. However, the Government authorities need to strike a balance while assessing these risks so that not all apps need to be certified under the law so that innovation is not hampered. It is indeed a very fine balance. General wellness apps or products such as apps tracking and assisting in maintaining healthy body weight, or products are generally kept out of the purview of law versus apps which tracks and assists in say monitoring blood sugar or other vitals or treats specific health issues or provides guidance for treatment of specific illnesses. The whole purpose to bring these apps under regulation is that there is a certain amount of rigour before the apps are released to the market and there are onus and responsibility on these makers. It should enable the app developers to be mindful of how is the product or app is advertised, claims as well. To protect consumers, certain jurisdictions, like Singapore, have mandated the manufacturers/ app developers to put a clarification statement on their product or on their apps. This statement should clearly state that this app or product is not intended to be used in a diagnosis, monitoring, management or treatment of any disease. Keeping all the innovation in health-tech space, India should provide guidance on SaMDs. The regulatory framework in India for medical devices is by the Central Drugs Standards Organization widely known as CDSCO. The new Medical Devices Rules, 2017 are comprehensive and now comprehensively covers almost 351 medical devices and about 247 in-vitro medical devices it still does not cover SaMDs. Given the increased use of mobile technology and awareness, guidelines on SaMDs could contribute to improving the affordability and availability of healthcare, including rural India, which has a huge user base. Gradual rigour in legislation will allow India to meet increased need, according to when resources for monitoring and enforcement become more available. India already follows the IMDRF regulations with respect to clinical trials and the clinical evaluation of medical devices, with respect to documents, licensing and safety standards.  Conclusion It is important for the legislation to allow the industry to grow and achieve its potential, especially in a country like India where there is a need for a better point of care medical solutions but at the same time provide unambiguous guidance. A good starting point would be a self-regulating mechanism with a set of standards, methods and procedures, clinical evaluation process. Such guidance would help improve innovation as well and guide the nascent Indian SaMD industry. Author: Manas Ingle http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.  Ibid.  Ibid.  http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-samd-ce.pdf NadimpalliRadhadevi et al., Regulatory guidelines for medical devices in India: An Overview, Department of Pharmaceutics, JSS College of Pharmacy, Asian Journal of Pharmaceutics, January- March 2012.