Healthcare software handles sensitive personal data, so compliance is a design concern, not a final check. This article covers the basics teams should understand before they build, and how to find out which rules apply to them.
Enforce access control on the server, every time
Access rules that exist only in the screen are not real protection. Each request that reads or changes sensitive data needs a server-side check, and that check should cover the specific record.
Make audit logs a core feature
- Log each access to a sensitive record: who, when, and what was viewed or changed.
- Store the logs apart from the operational database, and protect them from edits.
- Write logs in a way that does not slow down the main request.
Encrypt data by default
Encryption should be the normal setting for the whole system, not a switch that someone has to remember to turn on. Sensitive data should have no code path that leaves it unencrypted. Teams planning healthcare software compliance often start with our [enterprise software development](/services/enterprise-software-development) service, which covers scope, process and what is included.
Design for different rules
Different countries and certifications set different requirements. A system built on clear access control, audit logs and encryption can usually adapt to new rules. A system built without them often needs a redesign.
Companies in the UAE working on healthcare software compliance can see how we deliver it locally on our [enterprise software development in Dubai](/dubai/enterprise-software-development) page. We illustrate healthcare software compliance with a documented example: see the [patient platform concept](/case-studies/healthcare). Related reading: [API Security Checklist for Modern Applications](/blog/api-security-checklist).
Questions to ask your compliance team early
- Which rules apply to our product and our country?
- Who may see which data, and who approves access?
- How long must audit logs be kept, and who may read them?
Know which rules apply to your data
Healthcare software can fall under several regimes at once, depending on where it operates, who its users are and what data it handles. Confirm the obligations with qualified advisers for your jurisdiction before design begins. This article describes general engineering practice and is not legal advice.
Access control and audit trails
Access to health information should follow least privilege, so each role sees only what its work requires. Reads and writes of sensitive records should be logged with the user, the time and, where the workflow requires it, the reason. Audit logs must be protected from editing by the people whose actions they record.
Data handling from the start
Encrypt data in transit and at rest. Decide early where data is stored, how long it is kept and how it is deleted. Keep test environments free of real patient data, and use synthetic records for development and demonstrations.
Third parties that touch patient data
Every third-party service that handles patient data needs a contract that defines its responsibilities. Keep a current list of these services, and review it whenever the product adds a new integration.
Compliance starts with knowing which rules apply and designing access and logs from the first version. For a healthcare product, talk to your compliance team early, and see our work for healthcare organizations.