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DPDP for the Chief compliance officer in Healthcare

Reviewed by InfraVeritas360 ResearchFirst published Last reviewed

Sources: DPDP Act, 2023 and DPDP Rules, 2025 (MeitY) · Code of Medical Ethics, 2002 · MoHFW · Tamil Nadu health department FAQ · MTP Regulations

Your compliance calendar in a hospital already carries many health laws. DPDP adds duties that touch almost all of them.

Written for: Chief compliance officer, Healthcare and hospitals. Open this seat in the interactive tool

What is different here

The medical ethics regulations, PCPNDT, MTP, mental health, HIV, telemedicine and clinical trial rules each set their own consent, secrecy or retention duties. DPDP sits on top of these. The work is one register where every duty, including the health-law ones, has an owner and evidence.

The first four things to sort out

  1. Add DPDP duties to the register of health laws you already track.
  2. Name owners for the 72-hour record copy rule and the DPDP request register.
  3. Keep one page of clocks: record copies in 72 hours, CERT-In in six hours, the Data Protection Board report in 72 hours.
  4. Ask for operating evidence: access logs, consent records, PCPNDT and MTP retention.

A worked example

Chief compliance officer

Checking consent forms against every law

  1. Week 1Compliance lists every form: registration, procedure consent, research, teleconsultation and testimonials.
  2. Week 2The registration form bundles health package offers with treatment.
  3. Week 3A new version separates treatment, research, offers and stories into their own boxes.
  4. AfterEach form version is kept in the register with its date.

Evidence kept

  • Form list
  • Gap note
  • New form version
  • Register entry

Check each form against every law that applies, not just one.

What others in the sector usually do. Some hospital compliance teams link DPDP evidence to their NABH documentation, so one file serves both reviews.

Where it usually goes wrong, by organisation type

Organisation typeHotspots
Multi-specialty hospital chainShared logins on ward computers; Reports forwarded on messaging apps; VIP or staff records viewed out of curiosity
Standalone hospital or nursing homePaper case sheets at nursing stations; Vendor remote access to the hospital software; Records room with no access log
Diagnostic labs and imagingReport links sent to the wrong number; Franchisees keeping patient lists; PCPNDT records and images
Health-tech and telemedicineAnalytics and ad SDKs in health apps; Chat transcripts kept with no period; Sharing user data with partner pharmacies for offers
Pharmacy chain and e-pharmacyPrescription images in the app and with stores; Refill reminders used for marketing; Delivery partners with addresses and order details

10 questions the Chief compliance officer asks, answered in full

Do we need DPDP consent to treat a patient?

Short answer: Not for treatment; yes for extra uses

Usually not for the treatment itself. A patient who comes for care gives data voluntarily for that purpose, and a medical emergency involving a threat to life is a listed use. Clinical consent for procedures is a separate medical and legal requirement and stays. Extra uses such as research, marketing, testimonials and sharing beyond what care and billing need do require DPDP consent.

What the law says

Section 7(a) covers data given voluntarily for a specified purpose; Section 7(f) and 7(g) cover emergencies and epidemics. Section 7 · Section 6 · Section 5 · Rule 3

Steps
  1. Keep clinical consent forms as they are.
  2. Add a short notice at registration.
  3. Add separate boxes for research, offers and stories.
  4. Record which box each patient ticked.
  5. Train front desk to explain the difference.
Evidence to keep
  • Registration notice
  • Consent records for extra uses
Common mistakes
  • One form that bundles treatment and marketing
  • Calling clinical consent 'DPDP consent'
  • No notice at registration

Can we use patient data for research, audits or case studies?

Short answer: Consent or de-identification first

Research with identifiable patients needs informed consent under research rules and DPDP consent for that use. Clinical audit to improve care within the hospital usually fits the treatment purpose. Case studies and teaching material should be de-identified so patients cannot be recognised. Clinical trials follow the NDCT Rules, 2019.

What the law says

Section 6 sets consent; Section 17(2)(b) covers research only where no decision is taken about the person and prescribed standards are followed. Section 6 · Section 7 · Section 8(5) · Rule 6

Steps
  1. Route research through the ethics committee.
  2. Take research consent separately.
  3. De-identify teaching cases and photos.
  4. Limit researcher access.
  5. Delete or anonymise at the end.
Evidence to keep
  • Ethics approvals
  • Research consents
  • De-identification checks
Common mistakes
  • Photos with faces or tattoos in slides
  • Using records for studies without approval
  • Keeping research data with names after the study

Who owns accountability for personal data in practice?

Short answer: Named owners, accepted by them, for each duty

The organisation is accountable under the Act, and management decides who answers for each duty inside it. In practice that means a named owner for each duty and each major system, written down and accepted by that person. An owner whose name was typed in by someone else, without their agreement, is not really an owner.

From your seat: Chief compliance officer. Name an owner for every duty in one register approved by management.
What the law says

Section 8(1) puts responsibility on the Data Fiduciary. Section 8(9) asks for a published contact person. Section 8(1)–(2) · Section 8(9)–(10) · Rules 9, 14 · Section 10 · Rule 13

Steps
  1. List duties and major systems.
  2. Propose an owner for each.
  3. Ask each owner to accept in writing.
  4. Publish the overall contact person.
  5. Review owners when people move.
Evidence to keep
  • Owner register with acceptances
  • Published contact
  • Review dates
Common mistakes
  • Owners assigned without telling them
  • One person owning everything
  • Owners who left the organisation

Can a policy show that a control actually works?

Short answer: No; operation needs records

No. A policy shows what an organisation intends. It does not show that the control runs. To show operation you need records: a deletion log, an access review sign-off, a drill report, a sample of requests answered on time. Auditors and regulators look for these.

From your seat: Chief compliance officer. A policy is a starting point. Ask for the record that shows it working.
What the law says

Section 8(4) asks for appropriate technical and organisational measures to ensure compliance. Being able to show those measures work is part of meeting that duty. Section 8(5) · Rule 6 · Section 8(1)–(2)

Steps
  1. For each policy, write the record that would show it working.
  2. Check whether that record exists for the last quarter.
  3. Where it does not, start producing it.
  4. Sample a few records every quarter.
  5. Keep the samples with the policy.
Evidence to keep
  • Policy-to-record map
  • Quarterly samples
  • Gaps and actions
Common mistakes
  • Approving policies with no record behind them
  • Showing a policy when asked for evidence
  • Records that exist only before an audit

What should our privacy notice say, and where must people see it?

Short answer: Yes, at every point where you collect data

A notice must tell people, in plain words, what data you collect, why, how they can withdraw consent, how they can use their rights and how they can complain to the Data Protection Board. It has to stand on its own, separate from long terms and conditions, and be shown at the point where data is collected.

From your seat: Chief compliance officer. Keep a version history of every notice.
Example in Healthcare

Registration desks, appointment apps, lab forms and health-camp sign-ups need short notices in the languages patients speak.

What the law says

Section 5 and Rule 3 ask for a notice that can be understood on its own, with an itemised list of the data and the purpose for each item. Data you already hold from before the Act also needs a notice, as soon as reasonably practicable. Section 5 · Rule 3 · Section 6 · Sections 11–14 · Rule 14

Steps
  1. List every point where personal data comes in: forms, apps, counters, calls, emails, partner feeds.
  2. Write one short notice per collection point, with the data items and purpose side by side.
  3. Add how to withdraw consent, how to make a request and the DPO or contact person's details.
  4. Offer the notice in English and in the languages your patients actually use.
  5. Keep each version with the date it went live.
Evidence to keep
  • Screenshots or copies of the notice at each collection point, with dates
  • Notice version history
  • Translations, where used
Common mistakes
  • Hiding the notice inside terms and conditions
  • One notice for everything, with no link between data items and purposes
  • Forgetting old data collected before the Act

How do we handle a privacy complaint within 90 days?

Short answer: Reply within your published period, never beyond 90 days

Publish one clear way to complain, log every complaint, give it an owner and reply within the period you publish, never more than 90 days. People can go to the Data Protection Board only after using your process, so a good process keeps most matters with you.

From your seat: Chief compliance officer. Count the days on privacy complaints yourself.
Example in Healthcare

Patient relations already handles complaints. Tag the data ones and count the days.

What the law says

Section 8(10) requires a working grievance process. Rule 14(3) caps the reply time at 90 days. Section 13 says people must use your process before approaching the Board. Section 8(9)–(10) · Rules 9, 14 · Sections 11–14 · Rule 14 · Sections 18–26

Steps
  1. Publish one contact for privacy complaints on your website, app and notices.
  2. Log each complaint with the date, channel and a named owner.
  3. Acknowledge within a few days, and set an internal target well under 90 days.
  4. Find and fix the cause, not just the single case.
  5. Reply in writing and close the entry with the date.
Evidence to keep
  • Complaint register with dates
  • Replies sent
  • Monthly summary to management
Common mistakes
  • Mixing privacy complaints into general complaints with no tag
  • No owner, so nobody counts the days
  • Closing a complaint without fixing the cause

Something has gone wrong. What happens in the first 72 hours?

Short answer: Six hours for CERT-In; without delay for people and the Board; 72 hours for the detailed report

Contain it, then tell people. A reportable cyber incident goes to CERT-In within six hours of being noticed. Under DPDP, each affected person and the Data Protection Board must be told without delay, and the Board needs a detailed report within 72 hours. Sector regulators may have their own clock too.

From your seat: Chief compliance officer. Keep one page with every reporting clock that applies.
Example in Healthcare

A ransomware attack on the HIS needs a CERT-In report in six hours and the DPDP messages.

What the law says

Section 8(6) and Rule 7 set the DPDP steps. The CERT-In Directions of 28 April 2022 set the six-hour report. A breach includes accidental disclosure and loss of access, not only hacking. Section 8(6) · Rule 7 · Section 8(5) · Rule 6

Steps
  1. Name one incident lead and a back-up, with phone numbers that work at night.
  2. Write the first-hour steps: isolate, preserve logs, tell the DPO and the incident lead.
  3. Keep ready-made drafts for CERT-In, the regulator, the Board and affected people.
  4. Decide in advance who signs off each message.
  5. Rehearse once a year with the people who would actually be called.
Evidence to keep
  • Incident plan with clocks
  • Rehearsal record
  • Incident log with times of each step
Common mistakes
  • Waiting to finish the investigation before telling anyone
  • Treating a wrong email or a lost laptop as 'not a breach'
  • Only IT knowing the plan

Do we need a Data Protection Impact Assessment?

Short answer: Required only for SDFs; good practice for high-risk changes

By law, only Significant Data Fiduciaries must do a yearly impact assessment. For everyone else it is good practice for high-risk changes: new tracking, profiling, large data sharing, children's data or moving data abroad. A short assessment before the change is cheaper than fixing it later.

From your seat: Chief compliance officer. Use impact assessments for high-risk changes even if you are not an SDF.
What the law says

Section 10 and Rule 13 require a yearly impact assessment for Significant Data Fiduciaries. Section 10 · Rule 13 · Section 9 · Rules 10, 12 · Section 16 · Rule 15

Steps
  1. Define what counts as a high-risk change for you.
  2. Use a two-page template.
  3. Record the data, purpose, risks and safeguards.
  4. Get the DPO's view before approval.
  5. Keep it with the project record.
Evidence to keep
  • Assessment template
  • Completed assessments
  • DPO views
Common mistakes
  • Treating it as paperwork after launch
  • A 40-page template nobody completes
  • No trigger list

How do we put DPDP into the risk register?

Short answer: One line per duty, with owner and evidence

Turn each duty into a risk line with an owner, a control, evidence and a review date. Map controls you already run for your regulator, auditors or certifications, so the same evidence serves several purposes. Track vendor risk separately.

From your seat: Chief compliance officer. Link each DPDP duty to your compliance calendar.
Example in Healthcare

Add downtime and wrong-send lines.

What the law says

The Act sets duties in Sections 5 to 12. A risk register shows management where each duty stands. Section 8(1)–(2) · Section 8(5) · Rule 6 · Section 8(6) · Rule 7 · Section 10 · Rule 13

Steps
  1. List the duties that apply to you.
  2. For each, write the risk in plain words, the control and the owner.
  3. Link existing controls and audits as evidence.
  4. Rate likelihood and impact in your usual way.
  5. Review every quarter with management.
Evidence to keep
  • Risk register extract
  • Linked evidence
  • Quarterly review minutes
Common mistakes
  • One line saying 'DPDP compliance'
  • No owners
  • Evidence that is only a policy document

The sections you will use most

Other rules that sit alongside DPDP

RuleWhat it saysWhat it means alongside DPDPSource
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002Regulation 1.3.1: keep indoor patients' medical records for 3 years from the start of treatment. Regulation 1.3.2: issue records to patients, authorised attendants or legal authorities within 72 hours of a request. Regulation 2.2: keep patient confidences.Set retention at or above these minimums. Use the 72-hour record copy rule as the base for patient access requests.Code of Medical Ethics, 2002
Telemedicine Practice Guidelines, 2020 (Appendix 5 to the 2002 Regulations)Consent is implied when the patient starts a teleconsultation and must be explicit when a health worker or caregiver starts it. The doctor records consent and keeps logs, records and prescriptions as for in-person care.Telemedicine apps must add DPDP notices and protect chat, video and prescription data.MoHFW
Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994Records of tests and procedures, including Form F, must be preserved for 2 years, or until a legal proceeding ends.These records cannot be erased early on request; protect them carefully.Tamil Nadu health department FAQ
Medical Termination of Pregnancy Regulations, 2003The admission register is a secret document, kept by the head of the hospital, not open to inspection except under law, and kept for five years.MTP records need the tightest access in the hospital.MTP Regulations
Mental Healthcare Act, 2017Section 23: right to confidentiality. Section 24: no photos or information to media without consent. Section 25: right to access basic medical records.Psychiatry and counselling records need separate access and a careful request process.NHSRC copy of the Act
HIV and AIDS (Prevention and Control) Act, 2017HIV status may be disclosed only with informed consent, except in narrow cases. Establishments keeping HIV-related records must adopt data protection measures.Restrict HIV results and counselling notes to the treating team.Act
New Drugs and Clinical Trials Rules, 2019Informed consent of trial participants; ethics committees keep records for five years after the trial ends (Rule 13).Trial data needs both informed consent and DPDP safeguards.NDCT Rules
Drugs Rules: Schedule H1 registerPharmacies record prescriber's name and address, patient's name, drug and quantity, kept for three years.Keep the register for three years, then dispose of it.NHSRC
ABDM Health Data Management PolicyFor entities in the Ayushman Bharat Digital Mission, health records are shared through a consent manager, with consent artefacts for each request.If you are ABDM-linked, the ABDM consent flow and your DPDP notices must agree.ABDM / NHA
Clinical Establishments Act, 2010 and Rules, 2012 (states that adopted it)Registered establishments maintain medical records, and electronic records as the government specifies.Check whether your state follows this Act or its own nursing home law.MoHFW
IRDAI health insurance master circular, 2024Insurers decide cashless requests within one hour and final discharge within three hours.Fast TPA sharing is needed, but only the records the claim needs, through secure channels.IRDAI
CERT-In Directions, 2022Report specified cyber incidents within six hours; keep ICT logs 180 days in India.A ransomware attack needs a CERT-In report and the DPDP messages.CERT-In
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