Regulatory Domain
Healthcare is one of the fastest-growing sectors in India with an increase in focus by private players and a number of initiatives taken by the government. The market is more than US$ 100 billion and is predicted to reach US $275 Billion in the next five years. Thus, it has become necessary for the government to implement health policies in India and provide a regulatory framework. Many patients expect that healthcare service providers to deliver quality care and wish to receive timely warnings alerts on wellness negligence. They also demand patient observance solutions that are empowered by mobile devices (such as smartphones, tablets, etc.) and with applications. Mobile apps are developed as a new tool to connect in the healthcare field. Mobile healthcare applications are nowadays replacing the inactive techniques, for instance, Patients can now schedule an appointment with a physician just with a click from the smartphone through the respective application. New entrepreneurs and multinational companies are eyeing boost in the Healthcare industry through government initiatives like Digital India, Make in India and Start-up India. However, along with benefits there exists responsibility and obligations as well. For instance, all e-health, m-health, telemedicine applications are subject to techno legal agreements. Currently, the healthcare sector and healthcare startups in India are acting more on the side of the violation than compliances. Medical device firms and their applications must precisely obey Indian laws & principles. Medical device makers, application makers must also keep in mind the encryption laws of India and cloud computing-related accords of India. Although there is no particular law involved for players in this industry, you need to comply with several requirements associated with it. The list includes privacy law agreement, data protection obligations, cloud computing compliances, encryption/decryption compliances, cyber law due diligence, etc. It is mandatory for all present players or establishments to comply with obligations set by Clinical Establishments (Registration and Regulation) Act 2010 and the Clinical Establishments (Central Government) Rules 2012.
With India’s dynamic initiative on the development and implementation of digital health (eHealth) solutions, there is a need for a dedicated framework for communication between different stakeholders and regulations. Nonetheless, some positive initiatives are being taken by governments in India. For instance, the Electronic Health Record (EHR) Standards/Model of India is suggested along with a proposal for establishing a National E-Health Authority (NeHA) of India. Furthermore, if we remove the flaws in Digital India project, then the same can be used for digital health objectives as well. As of now, there is no mandatory obligation to provide e-delivery of services in India, and this is sufficient to avoid the same.
In Healthcare, the Privacy Standards and Security Standards are two important principles. Any health record system requires shields to ensure that the data is accessible when needed and that the information is not used, disclosed, retrieved, altered, or deleted improperly while being stored or transmitted. The Security Standards work concurrently with the Privacy Standards to create appropriate controls and security. Health sector bodies that are required to comply with the Privacy Standards must also obey the Security Standards.
Healthcare firms must reckon several components while adopting security measures. Companies need to implement appropriate safeguards to ensure confidentiality, integrity, and availability of all information they cover. They need to make sure that they are misused or disclosed, and their workforce complies with all security rules and principles.
India is yet to start acting on these aspects on the fronts of technology and legal frameworks. But there are reports that the Health Ministry of India has planned out a detailed e-health project under the Digital India program of the government. The project would include hospitals, electronic exchange of health records, online distribution of solutions, citizen portal, online monitoring procedures for services, and others.
Regulatory support will ease the approval process for devices and medical apps. The development of application capacity standards is an essential factor in gaining the assurance and confidence of healthcare suppliers, patients, and players involved.
Policy of electronic data exchange
In Healthcare, the Privacy Standards and Security Standards are two important principles. Any health record system requires shields to ensure that the data is accessible when needed and that the information is not used, disclosed, retrieved, altered, or deleted improperly while being stored or transmitted. The Security Standards work concurrently with the Privacy Standards to create appropriate controls and security. Health sector bodies that are required to comply with the Privacy Standards must also obey the Security Standards.
Healthcare firms must reckon several components while adopting security measures. Companies need to implement appropriate safeguards to ensure confidentiality, integrity, and availability of all information they cover. They need to make sure that they are misused or disclosed, and their workforce complies with all security rules and principles.
Ministry of Electronics and Information Technology deals with all aspects of electronic data exchange.
Website: meity.gov.in
These Security Standards fall into three categories viz. Technical, Physical, and Administrative.
Technical security standards
Department of National Cyber Safety and Security Standards handles all matters related to technical security.
Website: https://www.ncdrc.res.in
Healthcare providers must implement technical safeguards as part of its security plan to protect technical information of end users. It involves protecting technical information with the help of technology.
1. Authentication: Access to system and network is granted to authorized user, according to standards
2. Automatic Log-Off: An electronic session after a fixed time of inaction must be forcibly terminated, and to login back he/she will have to be a new session
3. Access control: Typically, only medical care providers should have access rights to a person’s clinical records. Management must record an audit log of all actions on user-defined events
4. Integrity: During data transfer, it must ensure that electronic healthcare information is not altered in transit in agreement with the standards specified
5. Encryption: Generally, all electronic medical information must be suitably encrypted and decrypted during data exchange as preference defined by organization
6. Digital Certificates: Digital Certificates usage for recognition and digital signing is advisable in health record system
Physical security standards
Physical standards are used to safeguard healthcare provider’s electronic information systems, related equipment, and the buildings housing the systems from hazards, and unauthorized invasion
1. Facility access control standard to limit actual physical access to electronic information systems and their facilities
2. Workstation use standard, to control the physical nature of a particular workstation or group of workstations, to maximize safety
3. A workstation security standard to execute physical guards to prevent the illegal access of a workstation
4. Device and media controls standard, to regulate the transfer of any electronic media containing protected health information from, to or within the facility
Administrative security standards
Administrative safeguards are proposed to ensure a full range of security. Hence they need to develop and execute a safety management process that involves policies and procedures which address security concerns.
1. Security governed standard which blocks security violations
2. Assigned security officer for the overall management
3. Workforce security management to ascertain end-user access privileges
4. Training staff members about security awareness
5. Establishing events procedures to handle security incidents
6. Incident planning to protect health information during unexpected event
7. Evaluation standards to evaluate security safeguards of an enterprise [1]
Healthcare Platforms/
i) There are several digital platforms offering online networking between medical consultants and patients.
ii) It is a virtual directory of selected specialties in medicine and avails fixation of appointment, case discussion etc.
iii) There is an element of window-shopping for the elective patients.
iv) Regulatory bodies do not stand guard for any such practice so far, with regard to the registration, licensing, indemnity insurance, quality, privacy and confidentiality issues.
v) The platforms are acting as marketing sites for the medicos.
vi) The compulsions of convenience, pressures in the government sector, ease with which life has become technology driven today and the comfort of proximity with a doctor on a “touch-screen” makes for the popularity and expansion of such networks.
IT IS EXPECTED THAT ONCE THE PANDEMIC CONTROL AND ERADICATION IS SUCCESSFUL, THESE PLATFORMS WOULD ALSO FIND WAYS FOR REGULARISATION AND RECOGNITION IN THE DIGITAL INDIA.
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