The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data for entities dealing with health information.

Digital health technologies must comply with HIPAA’s Privacy Rule, which requires the safeguarding of Protected Health Information (PHI), and the Security Rule, which sets standards for the secure electronic transmission of PHI.

Additionally, the Breach Notification Rule mandates entities to notify patients and relevant authorities in case of a data breach involving PHI.

How does the Privacy Rule impact digital health startups?

The Privacy Rule necessitates that digital health startups implement policies and procedures to protect PHI from unauthorized access.

This means strictly controlling who can access patient data and under what circumstances. Startups must also ensure patients have rights over their information, including the right to obtain and request corrections to their health records.

What technical safeguards are required under the Security Rule?

To comply with the Security Rule, digital health technologies must incorporate technical safeguards. These include access control, allowing only authorized personnel to access electronic PHI (ePHI), audit controls to monitor how ePHI is accessed and used, and integrity controls to ensure ePHI is not improperly altered or destroyed.

Encryption is also highly recommended to protect data during transmission over networks.

For a deeper understanding of how digital health and HIPAA privacy law intertwine, read Digital Health and HIPAA Privacy Law: What Tech Entrepreneurs Must Know.


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Leo Celis