Guest Post: From Advocate M.G.Kodandaram, IRS, Senior Member FDPPI
A New Chapter in Indian Healthcare
A quiet revolution is reshaping healthcare in India, not through grand infrastructure or cutting-edge equipment, but through a force far less visible yet profoundly transformative: DATA. Across cities and smaller towns alike, paper records are giving way to Electronic Health Records (EHRs), cloud platforms are enabling seamless remote diagnostics, and AI is becoming an invisible partner in clinical decision-making. Yet, behind this wave of innovation lies a critical imperative: Digital Responsibility.
That responsibility is no longer abstract, as it now rests on clearly defined legal and institutional foundations. On one side stands the National Accreditation Board for Hospitals & Healthcare Providers (NABH)[i], which launched its pioneering Digital Health Accreditation Standards. On the other is the Digital Personal Data Protection (DPDP) Act, 2023, India’s first comprehensive law dedicated to regulating the collection, processing, and protection of personal digital data. Together, these frameworks do not merely support the shift toward technology—they define how that shift must occur.
India’s healthcare system is undergoing a foundational transformation. What was once considered a strategic edge – ‘digitising healthcare systems’ – has become a non-negotiable operational and legal requirement.
As healthcare providers adopt digital tools like EHRs, telemedicine platforms, AI diagnostics, and wearable technologies, they are also navigating a complex regulatory landscape. This transformation demands more than efficiency—it calls for compliance, accountability, and ethical stewardship. Without strong safeguards for data privacy and quality assurance, digitalisation risks undermining the very trust it aims to build.
For years, going digital in healthcare was seen as a symbol of prestige or convenience. That perception has shifted. Today, as patients generate vast volumes of health information through mobile apps, diagnostics, and prescriptions, managing the underlying digital infrastructure has become just as critical as delivering clinical care.
Recognising this shift, NABH introduced its Digital Health Accreditation Programme in September 2023[ii]. Rather than leaving digital transformation to individual discretion, the initiative established a structured, scalable framework for evaluating digital maturity in hospitals. Institutions are now assessed across a three-tier scale – Silver, Gold, and Platinum – based on the safety, interoperability, and robustness of their digital systems. The framework is comprehensive, comprising 8 chapters, 38 standards, and 181 measurable elements, aimed at standardising digital excellence across the sector.
However, structure alone isn’t sufficient. As personal health data moves across platforms, institutions, and digital applications, Privacy and Security become paramount. This is where the DPDP Act, 2023 becomes vital. By classifying hospitals as “significant data fiduciaries,” the law imposes rigorous obligations around informed consent, data minimisation, purpose limitation, and breach reporting. In other words, handling patient data is no longer a matter of internal policy – it is now a statutory obligation, enforceable by law.
Taken together, the NABH and DPDP frameworks function like a double helix: one strand drives digital innovation and clinical quality, while the other enforces legal and ethical boundaries around patient data. Their combined influence marks a new era in Indian healthcare – one where digital system are not just tools of convenience, but guardians of compliance, care quality, and patient trust. An attempt is made, through this article, to understand the compliance standards prescribed under the said statutes.
Behind the Accreditation
Imagine a hospital where prescriptions are still scribbled, test results misplaced, and records scattered. Now contrast that with one where a patient’s journey – from consultation to surgery to post-discharge follow-up – is mapped, monitored, and managed through secure, interoperable systems. The difference is not just efficiency – it’s safety, privacy, and trust.
That is why the NABH Digital Health Accreditation Programme is transformative. It forces hospitals to think holistically. It’s not enough to buy a software license. Accreditation means building:
- Audit trails for every data entry
- Encrypted channels for doctor-patient communication
- Clear access controls so only the right eyes see sensitive data
It also means building systems that can speak to each other. In an age of telemedicine, labs, insurance APIs, and government health portals, interoperability is no longer a luxury.
Digital Health Toolkit
In today’s environment, patient data is generated, stored, and shared electronically – across departments, care providers, insurance entities, and even patients themselves. This transformation, while unlocking efficiency and precision in healthcare delivery, brings complex risks related to cybersecurity, data fragmentation, access control, and interoperability.
The NABH Digital Health Accreditation Programme[iii] addresses these challenges head-on by setting benchmarks that ensure:
- Secure digital infrastructure with audit trails;
- Encrypted communication protocols;
- Role-based access control to protect patient data;
- Patient-centric information systems that enable continuity of care;
- Defined protocols for when and how data can be accessed, shared, or destroyed.
These measures are no longer optional. Hospitals seeking accreditation, or aiming to enhance their public credibility and digital efficiency, must meet these baseline expectations.
The NABH didn’t stop at setting the bar—it also handed hospitals a roadmap in the form of a Digital Health Toolkit. Designed to guide institutions through the maze of digital transformation, the toolkit is structured into three phases:
- Planning
- Implementation
- Post-Go-Live
Of these, the Planning Phase is perhaps the most crucial. It’s the stage where vision meets logistics, where doctors and developers sit at the same table, and where the first mistakes – or successes – are often made.
The Planning Phase
For a hospital setting out to digitize, the Planning Phase is where it lays down its first principles – what kind of care it wants to offer, how it wants to protect patient trust, and what digital tools can enable that vision.
Step 1: Taking Stock: Before buying new systems, hospitals must assess what they already have. This means checking whether existing infrastructure—servers, networks, power backups—can support a digital overhaul. It also means studying how doctors and nurse work. Can current workflows adapt to a digital interface? Do staff need training to move from paper to pixels?
Step 2: Measuring Readiness: The NABH toolkit offers detailed checklists: HIS/EMR Readiness Assessments, IT Infrastructure Evaluations—tools that help convert vague ambitions into measurable preparedness. It’s like a health check-up for the hospital itself.
Step 3: Forming a Digital Vanguard: Transformation cannot be top-down. The NABH insists on a Steering Committee that includes clinicians, IT heads, administrators, and department leaders. This cross-functional team becomes the nerve centre of the digital transition—resolving issues, setting priorities, and ensuring that no department is left behind.
Step 4: Talking to People: Change is hard, especially in a field as sensitive as healthcare. So, hospitals must engage early. Town halls, orientation workshops, and even informal discussions are essential. Doctors may worry about screen time reducing patient time; nurses may fear errors in data entry. These concerns must be addressed head-on.
Step 5: Setting Realistic Goals: A good digital plan isn’t about ambition—it’s about clarity. Targets must be SMART: “Digitize 100% of outpatient prescriptions by June,” or “Ensure 95% compliance in access audits by year-end.” These are goals teams can rally behind.
Step 6: Planning Every Detail: Budgets, timelines, risk maps—everything must be documented. What if a vendor delays delivery? What if patient data needs to be migrated from a legacy system? Contingency planning is part of responsible digitalization.
Step 7: Choosing the Right Partners: Not all vendors are equal. The right one understands NABH standards, complies with the DPDP Act, and can integrate with insurance platforms and diagnostic systems. Due diligence—through RFPs, demos, and pilot runs—is non-negotiable.
Step 8: Defining the Must-Haves: Hospitals must define what digital success looks like. Is it just digital records? Or does it also include inventory tracking, billing integration, decision support systems, and consent management? Every module must align with both operational goals and legal mandates.
Laying the Ground for the Future
Once this Planning Phase is complete, hospitals don’t just have a project—they have a roadmap. The next stages—Implementation and Post-Go-Live—will bring their own challenges: user resistance, bugs, data inconsistencies. But if the groundwork is solid, these are hurdles, not roadblocks.
More importantly, a well-planned digital journey ensures that hospitals are not just keeping up with the times—they are staying ahead of legal, ethical, and clinical expectations.
The digital future of Indian healthcare isn’t waiting for anyone. Regulatory bodies like NABH are pushing forward. Laws like the DPDP Act are tightening the guardrails. And patients—armed with information and options—are demanding accountability.
Hospitals that treat digitalization as a checklist item may find themselves in a compliance quagmire. But those that treat it as an opportunity to reimagine care—as a patient-first, privacy-respecting, tech-enabled mission—will find themselves not just accredited, but trusted.
The DPDP Act in Hospitals
The DPDP Act, 2023, is not just a regulatory framework – it’s a new ethic, demanding that every byte of patient data be treated with the same seriousness as a life-saving drug. And for hospitals, particularly those aspiring to or maintaining NABH accreditation, compliance is no longer aspirational – it’s existential.
Complementing the NABH’s voluntary accreditation drive is the DPDP Act, 2023, India’s first comprehensive personal data protection law. Its impact on healthcare is both direct and profound. Healthcare providers manage sensitive personal data (SPD) such as biometric records, genetic data, and health conditions, and thus fall squarely within the high-risk category of data fiduciaries under the Act.
Hospitals must now:
- Obtain valid consent from patients for data collection and usage;
- Ensure purpose limitation and data minimization;
- Implement robust safeguards against breaches;
- Appoint data protection officers in some cases;
- Be ready to report data breaches in prescribed timeframes.
Together, the NABH standards and DPDP compliance do not merely represent regulatory obligations—they establish a framework that strengthens public trust, ensures ethical handling of sensitive data, and fosters operational excellence.
Bridging Compliance and Care
The DPDP Act requires a complete rethinking of how healthcare providers handle data. Hospitals must no longer consider data storage and transmission as backend tasks, but as core clinical functions integrated into every aspect of patient interaction.
Consider the case of a mid-sized urban hospital implementing a centralised EHR system post-DPDP. The IT team is no longer a support unit but a frontline department, ensuring encryption standards are met, user access is tightly regulated, and that audit trails are verifiable. But technical capability alone is not enough. As the legal requirements evolve, so must the understanding of clinicians, administrators, and even visiting consultants.
Consent Management Becomes Clinical: One of the most striking requirements under the DPDP Act is the mandate for explicit and informed consent for the use of personal data. This seemingly simple clause carries complex implications in hospital settings. Every lab test requisition, telemedicine consultation, or data sharing with insurance companies now demands a traceable record of patient consent. Hospitals are developing digital consent forms embedded into registration software, capturing date-stamped biometric or OTP-based approvals that are stored along with medical records.
The process has transformed front-desk operations. A receptionist is now trained not only in patient onboarding but also in explaining data usage policies, managing opt-in/opt-out requests, and triggering escalation mechanisms in case a patient refuses consent for secondary uses like research or marketing. Each refusal must be respected, logged, and implemented through technical filters on data access.
The Right to Access and Correction: A New Challenge
Patients under the DPDP Act are not passive subjects of data collection. They are recognised as Data Principals, endowed with the right to access, correct, and even delete their personal data. For hospitals, this introduces both a philosophical and procedural shift.
Imagine a scenario where a patient identifies a wrong allergy notation in their EHR. Earlier, such corrections might involve informal requests, internal memos, or manual overwrites. Now, under the new law, the hospital is expected to offer a digital grievance redressal interface, allowing the patient to initiate a structured correction request, which must be resolved within a stipulated time. Moreover, the correction must be traceable, with records of the original data, the corrected entry, and the authority approving the change.
While this introduces transparency, it also raises complex legal and medical questions. What happens when a correction request challenges a clinician’s judgment—say, a psychiatric diagnosis or a surgical recommendation? Legal teams and medical ethics committees will now need to work in tandem to devise policies that balance patient rights with professional autonomy.
From Human Error to Systemic Assurance: With digitisation comes automation, but also a new form of accountability. The DPDP Act insists on purpose limitation, meaning data collected for one medical purpose cannot be reused arbitrarily for another. This calls for data tagging within EHR systems—ensuring that every field, whether diagnostic or administrative, is linked to its lawful purpose of collection.
Hospitals must also assign Data Protection Officers (DPOs) or internal compliance leads who oversee system-wide adherence, report data breaches, and serve as the nodal point of contact for regulatory authorities. These roles are rapidly gaining prominence, and are often filled by professionals with dual training in law and information systems.
Breach Notification and Legal Exposure: The spectre of financial penalties under the DPDP Act—up to ₹250 crore—looms large over administrative boards. But the consequences extend beyond fines. A single breach of sensitive health data can irreparably damage a hospital’s reputation, provoke class-action lawsuits, or trigger investigations under other laws like the Information Technology Act, 2000, or the Indian Penal Code (soon to be replaced by the Bharatiya Nyaya Sanhita).
Consequently, breach reporting protocols must be codified. Any unauthorised access—whether via phishing, internal misconduct, or technical failure—must be logged, internally investigated, and in some cases, reported to the Data Protection Board. Hospitals are now investing in real-time intrusion detection systems, digital forensics teams, and third-party audits to bolster preparedness.
Interoperability vs. Privacy: The Policy Dilemma
As India pushes for a unified health stack under Ayushman Bharat Digital Mission (ABDM), hospitals are under pressure to make their systems interoperable with national databases. While this aids portability of care and improves outcomes, it also raises privacy concerns, especially when health data is linked with Aadhaar or insurance databases.
DPDP compliance demands that interoperability must never dilute consent norms. Every data-sharing interface must be equipped with user verification protocols, purpose declarations, and logging systems. In high-stakes contexts like medical research or epidemiological surveillance, data anonymisation becomes a prerequisite.
Hospitals engaging in clinical trials or partnerships with research bodies must now implement Privacy Impact Assessments (PIAs) and sign Data Sharing Agreements (DSAs) that define the scope, retention period, and destruction protocols of shared data. These agreements are increasingly becoming a standard compliance tool—drafted by legal counsel and enforced via software integrations.
Admissibility, Evidence, and Institutional Defensibility
The digital trail is not merely a compliance tool – it is a legal defence mechanism. Under the Bharatiya Sakshya Adhiniyam (BSA), 2023, electronically generated or scanned documents are admissible in court, provided they are accompanied by certificates of authenticity under Section 63 of the BSA (Refer Modernising Evidence Law: The Bharatiya Sakshya Adhiniyam, 2023 (BSA) in the Digital Age by the Author[iv]).
For hospitals, this means every digital record must be system-generated, time-stamped, and digitally signed or authenticated via a hash function. Internal SOPs must mandate that medical entries be made in real-time and on designated devices. For medico-legal cases—like assault injuries, MTPs, or custodial deaths—any compromise in data integrity can nullify the evidence in court.
Hospitals that automate this process with robust metadata management, access logs, and tamper-evident backups are best positioned to defend themselves legally. In fact, some institutions are now employing legal tech tools to automatically generate Section 63 certificates on demand, reducing delays in litigation or insurance claims.
From Legal Compliance to Institutional Culture
Despite the technical and legal rigour, full compliance cannot be achieved without a cultural shift within hospitals. Doctors, nurses, lab technicians, and billing executives must be trained not only on how to operate software but also on why compliance matters. Training sessions now include modules on:
- Recognising and preventing social engineering attacks (e.g., impersonation or phishing)
- Managing data disclosure requests from police or third parties
- Understanding the difference between medical necessity and legal obligation
- Filing incident reports for suspected breaches
Patient education is equally vital. Hospitals are beginning to include data privacy brochures in welcome kits, offer digital consent dashboards on tablets during admission, and launch awareness campaigns in OPDs and waiting areas.
Digital Ethics and the Future of Healthcare Governance
India’s healthcare landscape is undergoing a quiet revolution and at the heart of this transformation lies the growing imperative to treat patient data not just as information – but as a legal, ethical, and operational cornerstone of healthcare delivery.
What was once considered a backend function- “medical recordkeeping” has now emerged as a frontline compliance priority. The DPDP Act, with its stringent requirements on consent, purpose limitation, data minimisation, and breach accountability, has elevated the way healthcare institutions handle digital personal data. Unlike earlier frameworks, the DPDP Act provides individuals with strong enforceable rights, while imposing steep penalties for lapses, thus placing patient autonomy and privacy at the centre of every digital interaction.
In parallel, NABH standards have moved from generic quality guidelines to a more nuanced digital mandate. Hospitals are now expected to deploy Electronic Health Record (EHR) systems that don’t merely capture data but do so with integrity, traceability, and security. This means time-stamped entries, audit trails, encryption, real-time access control, and documented consent workflows – elements once associated with advanced tech infrastructure, now becoming basic prerequisites for accreditation and compliance.
Together, the DPDP Act and NABH form a dual regulatory lens – one focused on patient rights and data protection, the other on institutional governance and digital standardisation. Their convergence is forcing hospitals to rethink digital workflows, not as isolated IT upgrades, but as part of a broader legal-ethical framework. More importantly, this shift is not merely technical—it is cultural. Hospitals are being compelled to instil a digital hygiene mindset across staff levels, from doctors to data-entry operators. Every click, every view, and every transmission of patient data must now be justifiable, auditable, and aligned with both clinical and legal norms.
The digital shift is also fostering greater interdepartmental collaboration. Legal teams, IT departments, and medical professionals must now work in tandem to ensure that data security protocols are not just documented but lived. Training, periodic audits, breach readiness, and clarity in roles have become essential operational practices. The law is no longer on the periphery of hospital functioning—it is embedded in how care is administered, how records are retrieved, and how patients are communicated with.
Ultimately, this transformation is more than a compliance story—it is one of trust. Patients entrust hospitals not just with their lives, but with the most intimate details of their existence. When hospitals secure that data responsibly—when they ensure access is lawful, disclosures are transparent, and systems are resilient—they do more than follow the law. They honour that trust.
In a digital era, where data is the new diagnostic tool and privacy the new patient right, NABH standards and the DPDP Act are not just shaping healthcare compliance – they are shaping the very future of ethical, accountable, and patient-centric healthcare in India.
[ii] https://nabh.co/hospitals/
[iii]https://www.nabh.co/Announcement/Draft%20NABH%20Digital%20Health%20Standards%201st%20Edition.pdf
[iv] https://www.naavi.org/wp/modernising-evidence-law-the-bharatiya-sakshya-adhiniyam-2023-bsa-in-the-digital-age/
