As everything is going digital it is necessary to upgrade the pharmaceutical sector too. Since the advent of technology in the healthcare, the evolution increasing rapidly. New technologies emerged like wearable, telemedicine, and clinical decision making tools that use Artificial Intelligence, Machine learning etc. Central Drugs Standard Control Organisation (hereinafter referred as CDSCO) is taking due initiatives to make development in the health care sector with the help of software technologies and making new regulation to address the transformation.
What are the different classes of Software as Medical Device by the CDSCO?
CDSCO has classified the software as medical device in 4 classes in compliance with International Medical Device Regulators Forum risk classification. The classification is done on the basis of low risk, low moderate risk, moderate risk, high risk.
Class A – Class A comprises of those devices which is not directly interpret or interfere with the patient clinical data. In this class those software are added which record the pre medical conditions of the patient. This software has retrospective effect.
Class B – Class B comprises of those devices which provide electronic data of the patient but are not used for providing clinical diagnosis. For example Electrocardiograph software is used for home analysis and provides graphic data for cardiac arrhythmias.
Class C – Class C comprises of the devices which are used for disease diagnosis directly and are very important in the healthcare department. For e.g. Angiographic Coronary Vascular Physiologic Simulation software intended to aid in the identification of functionally significant cardiovascular disease.
Class D – Class D is not yet classified in India.
What are the recent developments in law?
The CDSCO has recently made amendment in the definition of medical devices under the Medical Device Rules, 2017. According to the new definition software is included in the medical device if it is used for one of the following reason:
- Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- Investigation, replacement or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- Disinfection of medical devices; and
- Control of conception
The World Health Organization (WHO) defines telemedicine as, “The delivery of health care services, where distance is the major factor, by all health care practitioner using information and communication technologies for the exchange of necessary information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.”
As we all witnesses in the Covid time that it was difficult to attend each and every patient physically and to give effective treatment to them. Then the need for more and more doctor arises and it was difficult to train medical practitioners in a very short span of time and also risk cannot be taken as the health of public at large was at stake.
Therefore, the concept of telemedicine is introduced. This is the combined project of Ministry of Health and Family Welfare and Department of Information Technology. The Government of India has set up a telemedicine portal for implementing a green field project on e-health establishing a National Medical College Network for interlinking the medical colleges across the country with the purpose of education and a National Rural Telemedicine Network for the e-Healthcare delivery.
What are the rules and regulations for Software as Medical Device?
The Software as Medical Device must comply with the following rules and regulations.
- O 648 (E) definition of medical device Notified on 11. 02.2020.
“All devices including instruments, implant, software etc to be used especially for human beings or animals which does not achieve primary intended actions by an pharmalogical or immunological will be defined as medical device.”
It is important to analyse the definition of medical device in order to understand whether the particular software falls in the preview of medical device or not.
- Medical Device Rules, 2017- The software specified as medical device must comply with the rules provided under the Medical Device Rules, 2017. Non compliance of the rules can attract the penalties provided under the rules such as cancellation of licence etc.
- ISO 13485: 2016- The document clarify the needs for quality management where a company needs to present its ability to provide medical device that fulfils customer and regulatory requirements. The company may involved in one or more stages, including design and development, production, storage and distribution, installation, or other related activities such as technical support.
- ISO 14971: 2019- The document defines terminology, principles and process for risk management of medical device inclusive software as medical device. The motive of this document is to guide the manufacturers of medical device to identify the risk associated with the medical device to measure and evaluate the associated risk, control and monitor the effectiveness of control.
Medically we are highly dependent on software as medical device for diagnosing, preventing, monitoring, and treating diseases; this makes it highly important to enact some data protection policies to prevent a data breach of patients’ personal and sensitive information. Keeping this in consideration, the Indian Parliament is working on the Personal Data Protection Bill (2019).
As the health sector is progressing in digital form, the Indian government and the CDSCO are taking necessary steps to determine device safety and moderate possible breach of user information. Few regulations are still under discussion and may come into force and regulate the Software as Medical Devices.
Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali