Tag Archives: data protection

DISHA: Data Ownership, Security, Consent for health data.

Acting on its vision for a National eHealth Authority (“NeHA”), the Ministry of Health and Welfare had introduced a draft bill for Digital Information Security in Healthcare Act (“DISHA” or “Draft Bill”).

DISHA’s main purpose, as per its preamble 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”. Our previous note on the overview of DISHA can be read here https://novojuris.com/2018/08/12/disha-the-future-direction-of-digital-health-information-in-india/). In this blog, we are covering aspects of data ownership, security, consent and others that DISHA proposes.

The Draft Bill defines digital health data as electronic data of an individual containing information about the individual’s medical records and health information and such individual would be considered as the owner of the digital health data. DISHA grants rights to owners of digital health data such as:

  1. The right to privacy, confidentiality and security of their digital health data.
  2. The right to refuse or give consent for generation and collection of digital health data by Clinical Establishments (a defined term which you can read in our previous blog here…).
  3. The right to refuse, give or withdraw consent for storage and transmission of digital health data.
  4. The right to refuse consent thereby restricting access to or disclosure of digital health data. However, it is not clear if the Clinical Establishment can still transmit under “reasonable use”, despite refusal by the data owner. It may be noted that reasonable use is used as a wide term.
  5. The right to ensure that the data collected is specific, relevant and not excessive in relation to the purpose sought.
  6. The right to know about the Clinical Establishments or entities which may have access to the data, the recipients to whom data has been transmitted or disclosed.
  7. The right to access the health data including their consent details and access of their data by any Clinical Establishment or any other entity.
  8. The right to possess the right to seek rectification of data by a Clinical Establishment in the form prescribed by NeHA.
  9. The right to necessarily mandate express prior permission before transmission or use of data in an identifiable form.
  10. The right to be notified each time their data is accessed by a Clinical Establishment.
  11. The right to ensure sharing of data with family members in case of health emergency.
  12. The right to prevent transmission or disclosure of sensitive data that may cause distress to the owner.
  13. The right to not be refused health services in case of refusal to give consent for any of the activities or data generation, collection, storage, transmission or disclosure.
  14. The right to seek compensation for damages cause as a result of breach of data.

DISHA lists down the purposes for which data is to be collected, stored, used which are:

  1. Advancement of delivery of patient centred medical care.
  2. Appropriate information for guiding sound medical decisions at time and place of treatment
  3. Improvement of coordination of care and information among hospitals, laboratories, medical professionals through an effective infrastructure for secure and authorised exchange of data.
  4. Improvement of public health activities and facilitation of early identification and rapid response to public health threats, such as disease outbreaks and bioterrorism.
  5. Facilitation of health and clinical research and health care quality
  6. Promotion of early detection, prevention and management of chronic diseases.
  7. Carrying out public health research, policy formulation, review and analysis.
  8. Undertaking of academic research and related purposes.

Under the Draft Bill the usage of personally identifiable information can be undertaken only for advancement of delivery of patient centred medical care, appropriate information for guiding sound medical decisions at time and place of treatment and improvement of coordination of care and information among hospitals, laboratories, medical professionals through an effective infrastructure for secure and authorised exchange of data to extent of ownership rights and in the best interest of the owner. The usage of data for public health related purposes shall be undertaken only after anonymisation and de-identification of data.

No data collected shall be used for any purpose other than what has been prescribed, be provided access to or disclosure of personally identifiable information without express consent of the owner or a statutory or legal requirement. The data collected shall not be used for commercial purpose or disclosed to insurance companies, employers, human resource consultants and pharmaceutical companies, irrespective of such data being identifiable or anonymised. However, the insurance companies may seek consent of the data owner to access such data for the purpose of processing insurance claims.

A Clinical Establishment may, by consent of the owner, collect the health data after informing the owner about the ownership rights, purpose of data collection, identity of data recipients to whom data may be transmitted or disclosed or who may have access to data on a need-to-know basis. A copy of the consent form is to be provided to the owner. Moreover, an entity that engages in collection of health data would be regarded as the custodian of such data and would be responsible for protection of such data. In case the owner is incapacitated or incompetent to provide consent, the same shall be obtained from a nominated representative, one having legal capacity to give consent. In the event the person becomes competent to give consent, the owner would have the right to seek withdrawal of consent given by nominated representative and seek consent of owner for collection of health data as prescribed by NeHA. This option to consent through a nominated representative extends in the case of collection of health data of a minor as well with the minor having the option to seek withdrawal of consent of the nominated representative to give own consent.

DISHA prescribes that the storage of digital health data so collected would be held in trust for the owner and the holder of such data would be considered as the custodian of data thereby making such holder responsible to protect privacy, confidentiality and security of data. The holder of data could be a Clinical Establishment or a Health Information Exchange.

Storage of digital health data shall be stored only by a Clinical Establishment or a Health Information Exchange and shall be held on behalf of NeHA and shall be subjected to such usage as has been prescribed without compromising on the privacy or confidentiality of such data or owner.

The transmission of digital health data is required to be transmitted by a Clinical Establishment to a health information exchange in an encrypted form for reasonable use as per standards prescribed by NeHA keeping in mind the privacy and confidentiality of the owner. A Clinical Establishment or health information exchange would be allowed to transmit the digital health data only after obtaining the prior consent of the owner and giving information to the owner about their ownership rights and the purpose of collection of data. Moreover, a health information exchange is also under an obligation to maintain registers containing information regarding any and all transmissions of digital health data between Clinical Establishments and health information exchanges and between health exchanges.

The digital data collected, stored or transmitted by a Clinical Establishment or a health information exchange may be accessed by a Clinical Establishment on a need-to-know basis. Access to digital health data may be sought by the governmental departments by their secretaries in de-identified or anonymised form by submitting a request to NeHA in furtherance of public usage of health records. Moreover, access may be granted to digital health data for purpose of investigation into cognizable offences or for administration of justice subsequent to order of a competent court. In the case of emergencies, the Clinical Establishments may be granted access to the digital health data of the patient and the relatives of the owner may also be given access to the data for correct treatment of the owner. Moreover, all Clinical Establishments and health information exchanges are required to maintain registers to record purpose and usage of digital health data so accessed in a manner prescribed by NeHA.

Under DISHA, the Clinical Establishments, health information exchanges, SeHA, NeHA are duty bound to protect the privacy, confidentiality and security of digital health data of the owner. Such duty also extends to an entity which has generated and collected digital health data. Such duty is to be given effect to by undertaking necessary measures to ensure that data collected, stored, transmitted is secured and protected against unauthorised access, use or disclosure and against accidental or intentional destruction, loss or damage.

The Clinical Establishments or health information exchanges are required to notify the owners of data in cases of breach or serious breach of digital health data within 3 (three) working days. The Draft Bill does not clarify if the 3 days is to be calculated from the date of breach or from the date of becoming aware of a breach.

Some observations:

  1. The Draft Bill must identify a competent court that is authorised to pass an order for usage of data.
  2. The Draft Bill fails to provide for a penalty on Clinical Establishments and health information exchanges for storage of incorrect digital health data.
  3. The time of 3 working days for intimation of breach, may have to be 3 days and not necessarily “working” days.
  4. Although the entities have a duty to protect the data of the owner, the duty to notify the owners in cases of breach of information doesn’t extend to entities and has been limited only to Clinical Establishments and health information exchanges.
  5. The Draft Bill must provide for Right to be Forgotten.
  6. The Draft Bill must provide for a cohesive reading with (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011, under the Information Technology Act.
  7. We hope that there will be sufficient Rules under the Draft Bill which can provide for specific consent specifically to certain acts and not a blanket consent.
  8. The Draft Bill should provide for specific time period for record maintenance.

Author : Mr. Spandan Saxena

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DISHA – The future direction of digital health information in India

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.

Author: Manas Ingle