Key Takeaways
- Health data is sensitive personal data requiring strong safeguards under the DPDP Act.
- Teleconsultation features must follow Telemedicine Practice Guidelines.
- Software intended for diagnosis or treatment may fall under medical device regulations.
- Consult legal and regulatory experts for your specific product.
Healthcare apps face more regulatory scrutiny than typical apps. Planning compliance early avoids costly redesigns.
Key compliance areas
| Area | What to consider |
|---|---|
| DPDP Act | Consent, purpose limitation, security safeguards, breach notification |
| Telemedicine Practice Guidelines | Doctor registration, consultation modes, prescriptions |
| ABDM | ABHA, consent-based record sharing, standards |
| Medical device rules | Software with diagnostic/therapeutic intent may need regulatory approval |
| Drug and pharmacy laws | Online medicine sales, prescriptions |
Security checklist
- Encryption in transit and at rest
- Role-based access and audit logs
- Indian hosting where preferred
- Regular security testing
- Incident response plan
See patient data security and DPDP.
Disclaimer: General information, not legal advice.
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Frequently Asked Questions
Does the DPDP Act apply to health apps?
Yes, apps processing personal data, including health data, must comply with DPDP obligations.
Is my health app a medical device?
If the software is intended for diagnosis, prevention, monitoring or treatment, it may be regulated; seek expert advice.
Do health apps need ABDM integration?
Not always mandatory, but recommended for interoperability.
How should health data be stored?
Securely, with encryption, access controls and audit logs.
