India: Digital Information Security In Healthcare Act

Last Updated: 13 April 2018
Article by Trilegal .

The proposed Digital Health Information Security Act seeks to regulate the generation, collection, storage, transmission, access and use of all digital health data. This legislation covers within its ambit clinical establishments, insurance companies and employers that collect health information, and IoT, manufacturers of wearables and other entities that deal with digital health data. The draft legislation is open for comments until 21 April 2018.


The Ministry of Health and Family Welfare has, by notification dated 21 March 2018, published the draft Digital Information Security in Healthcare, Act (DISHA), inviting public comments. The DISHA lays down provisions that regulate the generation, collection, access, storage, transmission and use of Digital Health Data (DHD) and associated personally identifiable information (PII).

DHD is an electronic record of health-related information about an individual and includes information relating to:

(a) an individual's physical or mental health;

(b) any health service provided to such individual;

(c) donation by the individual of any body part or any bodily substance;

(d) testing or examination of a body part or bodily substance of the individual or information that is collected while providing health services to the individual; or

(e) details of the clinical establishment accessed by the individual.

Further, PII is defined as any information that can be used to uniquely identify, contact or locate an individual specifically or along with other sources. An illustrative list of such information has been specified in Schedule I to the DISHA. This list includes information such as name, address, date of birth, vehicle number, financial information etc.

The legislation creates a central regulator called the National Electronic Health Authority (NeHA), and various State Electronic Health Authorities (SeHA) to give effect to the provisions of the DISHA.

A brief overview of the salient provisions of this legislation is given below.

Salient Features

Regulated Entities under the DISHA

The DISHA primarily regulates Clinical Establishments (which include clinics and pathology labs, but excludes pharmacies, insurers and other data controllers/processers in the healthcare sector) as well as any other entities that generate, collect, access, transmit or use DHD or associated personal health information. The DISHA also empowers the Central Government to establish entities called Health Information Exchanges that allow Clinical Establishments to exchange DHD with each other.

Ownership of Data and the Rights of the Data Subject

The DISHA states that all DHD is owned by the individual providing such data (the Owner). The DISHA confers various affirmative rights that the Owner may exercise with respect to this DHD. These rights include:

(a) The right to privacy, confidentiality and security of this data;

(b) The right to give or refuse consent for the generation, collection, storage, transmission, access or disclosure of this data. The owner may not be refused a health service if they exercise the right to refuse consent;

(c) The right to access their DHD and the right to rectify inaccurate or incomplete DHD;

(d) The right to require the Owner's explicit permission for each instance of transmission or use of their DHD; and

(e) The right to seek compensation for damages caused by a breach of DHD.

The Collection and Processing of DHD

The entities that collect and process DHD are required to meet certain obligations specified under the DISHA while carrying out these activities. For a brief summary of these obligations please click here.

Further the DISHA provides that any DHD, stored or transmitted by a Clinical Establishment, may be accessed on a 'need to know basis' i.e. by a specific person for a specific and lawful purpose, where such access of digital health data is necessary for that purpose or to carry out that function. Clinical Establishments and Health Information Exchanges may also use PII for purposes related to the treatment of the patient provided they are able to demonstrate that such use was necessary for that purpose. While entities other than Clinical Establishments or Health Information Exchanges may generate, collect and store this data for purposes related to the treatment of the patient, they can only use this information with the consent of the patient.

The DISHA allows anonymised or de-identified data to be used for specific public health purposes. These include early identification and prevention of diseases and research for public health, clinical and academic purposes. However, it strictly prohibits access, use or disclosure of DHD (whether in identifiable or anonymised form) by any other entity for a commercial purpose. It also prohibits the use, access or disclosure of DHD by employers, insurance companies, human resource consultants and pharmaceutical companies under any circumstances. Insurance companies can access an Owner's DHD from the Clinical Establishment to which an insurance claim relates but only for the purpose of processing that claim.

The blanket prohibition on the use of DHD by insurance companies seems to imply a restriction on the use of this data more broadly for actuarial purposes. Similarly, while the DISHA allows the use of DHD for academic, clinical and public health research, it expressly prohibits the access, use or disclosure of DHD, whether identifiable or anonymised, by pharmaceutical companies.

Currently, employers can process health data for employee benefits, office records and insurance purposes under labour legislations like Maternity Benefits Act, Employee Compensation Act and Employee State Insurance Corporation Act and as part of their internal policies. In line with this, the DISHA allows the use of DHD by employers to the extent required by law. However, access, use or disclosure of DHD to employers or human resource consultants for any other purpose is prohibited under the DISHA.

While the DISHA allows healthcare businesses to use DHD to advance patient centred medical care and other core functions, the use of DHD for any 'commercial purpose' is expressly barred. The term 'commercial purpose' is however not defined. It is therefore unclear whether marketing of treatments, appointments or referrals by hospitals or other business to their clients may be struck by this prohibition.

Data Breach Notification

The DISHA casts an obligation upon Clinical Establishments and Health Information Exchanges to provide notice to the Owner in case of any breach or serious breach of DHD within 3 days.

A breach of DHD can either be a breach or a serious breach of data. A breach of DHD is defined to mean the collection and otherwise handling of this data (a) in contravention of the Act, (b) in a manner that violates the rights of the Owner, or (c) that results in the damage, deletion or alteration of data. A breach of DHD gives rise to a claim for compensation from the person who breached the data.

A serious breach of DHD on the other hand, is:

(a) any breach of data that is carried out intentionally, dishonestly, fraudulently or negligently;

(b) a breach of data that relates to data that is not de-identified or anonymised;

(c) the use of DHD for commercial purposes or commercial gain; or

(d) a repeated breach of DHD by any entity, Clinical Establishment or Health Information Exchange.

A serious breach of data is punishable with an imprisonment which may extend from three to five years, or a fine. It can be grounds for a claim for compensation from the person who breached the data. No cap has been prescribed for the compensation that may be granted.

In addition, the DISHA creates various other offences including the unauthorised access of another person's DHD and data theft. These offences are punishable with imprisonment which may extend up to five years.

Adjudication and Enforcement

The DISHA sets up adjudicatory bodies at the state level as well as one at the central level. Appeals from orders of the state adjudicatory authorities can be heard by the central adjudicatory body. Appeals from the central adjudicatory authority lie with the Delhi High Court.

Offences that carry criminal consequences are to be tried before a Court that is not inferior to that of a Court of Sessions. A complaint for these offences may be made by the Central Government, the State Government, the NeHA, the SeHA, or an affected person.

The draft is open to comments by the public till 21 April 2018. Comments may be submitted by email to

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions