The Ministry of Health and Welfare in the year 2015 published a note on establishing a National eHealth Authority ("NeHA") to regulate the emerging usage of electronic mediums in healthcare, especially for maintenance of e-Health records and digital health information across India. The goal of NeHA is "to ensure development and promotion of eHealth ecosystem in India for enabling, the organization, management and provision of effective people-centred health services to all in an efficient, cost-effective and transparent manner".
The Ministry Health and Welfare ("Ministry"), eHealth Department has been working on developing international standards for creating, maintaining and storing of eHealth records. There were circulars in 2013 and 2016 providing guidelines and specific standards to be adopted and implemented by hospitals, medical professionals and other stakeholders in the healthcare industry, which were not mandatory, but definitely a step forward in digitising health care records.
Innovations in integrating healthcare and technology is helping a large population to access healthcare. Acting on its vision for NeHA, the Ministry had introduced a draft bill for Digital Information Security in Healthcare Act ("DISHA" or "Draft Bill").
DISHA'S main purpose, as per the pre-amble is to (i) establish NeHA, State eHealth Authorities ("SeHA") and Health Information Exchanges; (ii) standardise and regulate the process related to collection, storing, transmission and use of digital health data; (iii) and to ensure reliability, data privacy, confidentiality and security of digital health data".
DISHA aims to have a national as well state level implication and aims to regulate the digital health data in a federal structure i.e. NeHA being a central and an apex authority under the Bill established by the Central Government as per the provisions of this Bill and SeHA being a state level authority established by the respective State Governments. Further the Central Government shall establish as many Health Information Exchanges as necessary. Further under the act there has to be National level and State level executive committees which will aid and assist NeHA and SeHAs in the performance of their functions under DISHA.
DISHA, is applicable to clinical establishments which includes medical institutions and individuals performing and providing any kind or form of medical and healthcare services excluding hospitals owned and operated by the army, navy and the air force. However, it includes clinical establishments which are owned and operated by government or a department of government.
Further these clinical establishments can only collect digital health information for certain particular purposes which are more or less related to providing medical and healthcare services to owners of the digital health information. DISHA makes clear that digital health in any form i.e. whether identifiable or anonymized, shall not be accessed, used or disclosed to any person for commercial purposes.
The Draft Bill enumerates the functions of NeHA and SeHA ("Authorities") which are to:
- formulate standards, guidelines and protocols for generation, collection, storage and transmission of the digital health data.
- define protocols to safeguard the data from any theft or breach and to provide for data security measures at each level of processing of data, which shall at least include access controls, encryption and audit trails.
- lay down protocols for transmission of digital health data to and receiving it from other countries.
- provide for standards for establishing necessary norms and standards for certifying digital healthcare data systems and stakeholders.
- conduct regular checks and investigations to ensure compliance with law.
One of the key aspects of DISHA is to establish Digital Health Exchanges; digital health information exchange ("DHIE") allows doctors, nurses, pharmacists, other health care providers and patients to access and securely share a patient's vital medical information electronically—improving the speed, quality, safety and cost of patient care. Any and all transmission of digital health information will happen through these exchanges. The intention under DISHA is to store and keep all the digital health data in these DHIEs located across India. This can only be possible if the digital health information is standardised i.e. it is maintained in same format by all and therefore the Ministry primarily introduced the eHealth record standards and now through DISHA wants to integrate the eHealth records and provide the whole digital healthcare system a proper structure under these DHIEs. It would be good if the Government can aggressively promote data centres across India.
Under the Draft Bill, DHIEs will be monitored and controlled by their respective Chief Health Information Executive whose duties primarily will be to take care of the DHIEs day to day affairs, to access and further transmit the digital health information appropriately as transmitted by clinical establishments, notify the data breach to a data owner and store the data appropriately.
At the outset this looks like a fairly centralised system of data storage and therefore the same may be vulnerable to cyber threats and data breaches. One of the ideas that can be considered is to store eHealth records using block-chain technology to make the DHIEs more secure.
DISHA elaborates ways to protect the data and has brought in the concept of "data ownership" i.e. digital health data under the Draft Bill is explicitly owned by the person of whose digital health data is generated and processed. Section 31 of the Draft Bill, states that individuals are the owners of the digital health data and clinical establishments and DHIEs are custodians of the digital health information and have a duty of trust to maintain confidentiality and security of such data.
The Draft Bill explicitly describes the roles and responsibilities at the time of collection of data, transmission, anonymisation and de-identification of data. The data owner has to provide explicit consent to various actions that can be taken on the data. The Bill also provides individuals with a right to rectify their digital health data which might be inaccurate and incomplete, a right to have obtain explicit consent in each and every instance of transmission of data, right to be notified, right to prevent disclosure of digital health data under certain circumstances, right to not to be refused of any health services.
A breach under DISHA is of two types, (i) breach of digital health data and (ii) Serious breach of digital health data. Serious breaches are detailed to include cases where a person or an entity or a clinical establishment breaches digital health data intentionally or if digital health data is used for commercial purposes, or breach occurs where the digital health data was not in de-identified or anonymized form.
Punishment for a breach of digital health data is that "A person shall be liable to pay damages by way of compensation to the owner of the digital healthcare data in relation to which the breach took place". Serious breaches are punishable with imprisonment as well.
While DISHA appears to be conceived with the right intent, there are certain aspects which has to be thought through in more depth.
- The many mobile apps which collects huge amounts of health data in order to provide tracking/monitoring for the users or apps which are aggregators of medical practitioners and providers or apps which are market-places for medical practitioners, pharmacists etc. or apps which connect medical practitioners with patients. These apps are not part of the definition of "Clinical Establishment" to whom the law applies.
- With India proposing new legislation for data protection and privacy, it has to be seen how this Draft Bill inter-relates.
- It is believed that block-chain technology might help in keeping the data secure. This is already being used in Estonia.
- DISHA prohibits the use of digital health information for commercial purpose, whether in anonymized or de-identifiable form. However, operationalizing of collection and transmission should be more robust and India has seen "Aadhar" related mis-use of personal data.
- Sharing of data on "need to know basis" seems wide and it would be essential to perhaps either through the Rules under the Draft Bill can make it more specific.
- Compensation for data breaches, including adjudication has to have some specific and strict timelines.
DISHA is definitely a right direction but should have to maintain the fine balance in enabling innovation in health-care, government's requirement of data, protecting the data-owners' rights in a swift and efficient manner, making it easy for the medical practitioners and other stakeholders in the healthcare industry to make this robust.
Over the next blog, we will detail the consent, information that can/ cannot be collected etc.
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