Understanding the Health Insurance Portability and Accountability Act requirements for mobile health applications.
The Health Insurance Portability and Accountability Act (HIPAA) establishes national standards to protect sensitive patient health information (PHI) from being disclosed without the patient's consent or knowledge.
Mobile health apps that handle Protected Health Information (PHI) must comply with HIPAA's Security Rule, which specifies administrative, physical, and technical safeguards.
HIPAA violations can result in penalties up to $1.5 million per year for each violation category, plus potential criminal charges.
Required protections for mobile apps handling PHI
Implement policies and procedures to prevent, detect, and correct security violations.
Mobile apps must have documented security policies and incident response procedures.
Ensure workforce members have appropriate access to ePHI.
Implement role-based access controls and user authentication within mobile apps.
Implement security awareness and training program.
Include mobile security best practices in user documentation and onboarding.
Limit physical access to electronic information systems.
Mobile devices must require screen locks and biometric authentication.
Govern receipt and removal of hardware and electronic media.
Implement remote wipe capabilities and secure data deletion on app uninstall.
Allow access only to authorized persons or software programs.
Implement unique user identification, automatic logoff, and encryption.
Record and examine activity in systems containing ePHI.
Log all access to PHI within the mobile app with timestamps and user IDs.
Protect ePHI from improper alteration or destruction.
Use checksums and digital signatures to verify data integrity.
Guard against unauthorized access during transmission.
Encrypt all PHI in transit using TLS 1.2+ with certificate pinning.
Scan your healthcare app against HIPAA technical safeguards and identify potential compliance gaps.
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