Anyone in the US Health and Dental profession must follow the strict Health Insurance Portability and Accountability Act (HIPAA) regulations related to protecting patient health information (PHI). With more and more mobile health apps being developed, telehealth app developers need to create HIPAA-compliant apps. However, securing PHI on mobile is a complex task.
Understanding HIPAA Regulations for Mobile Apps
If your app creates, receives, maintains, or transmits PHI from or on behalf of a HIPAA-covered entity, then your app has to adhere to HIPAA regulations. This includes:
- Privacy Rule. Requires safeguarding PHI confidentiality and giving patients control over their data.
- Security Rule. Sets administrative, physical, and technical safeguards for securing PHI.
- Breach Notification Rule. Requires disclosing PHI breaches affecting 500+ individuals.
Names, birth dates, social security numbers, diagnosis codes, treatment information, and more are examples of PHI.
HIPAA violations can lead to civil monetary penalties of 100 to 50,000 per violation (up to 1.5 million per year). Criminal penalties can result in fines up to 250,000 and ten years imprisonment.
In fact, a recent survey found that 25 percent of covered entities experienced a mobile security incident in the last year. Since mobile apps are becoming more integrated into healthcare, HIPAA compliance is essential.
Securing PHI Within Mobile Apps
Securing PHI on mobile devices presents unique challenges:
- Mobile apps rely on third-party services and SDKs that may not be HIPAA-compliant
- Device vulnerabilities provide more attack surfaces to secure PHI
- Small screens make implementing complex access controls difficult
- BYOD (bring your own device) policies limit what app developers can control
A multi-layered defense strategy is essential:
- Verify that third-party services and SDKs handle PHI appropriately
- Encrypt PHI in transit and at rest
- Secure user authentication and authorization
- Monitor app activity to detect improper PHI access
- Validate app security controls through audits
The app architecture must have proper PHI security controls embedded in it without compromising usability.
Vetting Third-Party SDKs and Services
Third-party SDKs (software development kits) or a backend-as-a-service (BaaS) provider might speed up development. However, they also introduce risk.
Developers must assess:
- How SDKs and services access, use, and disclose PHI
- If adequate administrative, physical, and technical safeguards are in place
- If breach notification procedures must be HIPAA-compliant
For example, crash-reporting SDKs usually send device data back to the SDK provider to fix bugs. This could unintentionally leak PHI. Using a HIPAA business associate agreement (BAA) binds third parties to be HIPAA-compliant.
Before integration, it is highly recommended to audit SDK behavior with static and dynamic analysis tools.
Authenticating Users
Implementing “facility access controls” only restricts system access to authorized users. In mobile, this means having strong user authentication.
Common mobile authentication methods include:
- Usernames and passwords
- Multi-factor authentication (MFA)
- Biometrics like fingerprints or facial recognition
- Custom tokens or keys
Considerations for HIPAA mobile authentication include:
- Allowing complex password policies
- Encrypting authentication credentials and tokens
- Handling lost or stolen credentials and devices
- Detecting brute force login attempts
- Supporting user logout and auto-logout after inactivity
For example, using single-factor authentication with short passwords would not be HIPAA-compliant.
Security and usability must be balanced properly for authentication on mobile. MFA adds more steps for the users, but it makes PHI safe.
Authorizing User Access
The Security Rule mandates establishing “access controls” that grant access to “authorized persons” for PHI. Role-based access controls must be implemented to define the permissions that authenticate users to access systems.
For a mobile healthcare app, this could mean:
- Patients can only access their personal PHI
- Nurses can view PHI for patients assigned to them
- Doctors can see all patients ‘ PHI
- Admins manage user roles and permissions
Access policies have to be granular and map to the mobile app features. For example, you could restrict access to user roles that would have PHI upload/download features.
Other access control challenges include:
- Preventing the co-mingling of PHI between patients
- Disabling access when users are no longer authorized
- Creating detailed audit trails of user access
However, access policies need to be managed as user roles, where healthcare workflows do not allow for such flexibility.
Encrypting PHI
Covered entities are required by the HIPAA Security Rule to ‘encrypt and decrypt electronic protected health information whenever appropriate.’
On mobile devices, PHI should always be encrypted in transit over networks and at rest when stored.
Encryption best practices for mobile apps include:
- Use TLS 1.2+ for transmitting PHI
- Encrypt databases and file systems storing PHI
- Leverage native device encryption features like iOS Data Protection
- Only store encryption keys in device-secure elements
- Validate that no PHI is stored unencrypted during audits
Encryption keys must also be maintained and approved government encryption standards must be used, such as AES-256.
Enabling Secure PHI Sharing
Sharing PHI between patients and providers is core to healthcare apps. Developers must assess sharing risks:
- Can users accidentally share PHI with the wrong party?
- Are there notifications when PHI is viewed or shared?
- Do transfers occur over secure channels?
Common sharing challenges include:
- SMS messaging PHI with unencrypted channels
- Emailing PHI with improper access controls
- Using external file-sharing apps that leave auditing gaps
Secure sharing techniques include:
- Encrypting content before external sharing
- Integrating secure messaging features directly into apps
- Maintaining detailed activity logs of all PHI transactions
- Prompting logins before external PHI-sharing links can be opened
Validating PHI sharing controls through extensive user testing and audits is key to preventing data leakage.
Detecting Security Incidents
HIPAA requires active monitoring systems storing PHI to detect potential breaches. On mobile apps, this could include:
- Analyzing crash reports for signs of a data compromise
- Detecting abnormal spikes in failed login attempts
- Noticing unusual PHI sharing or access patterns
- Identifying malicious app behavior through anomaly detection
Mobile device management (MDM) tools give visibility into the monitoring app behavior. The MDMs can scan the devices, impose encryption, and even remotely wipe them.
App developers must also implement incident response plans for security events like:
- Users losing mobile devices with PHI stored locally
- PHI accessed by unauthorized parties
- Unintended PHI disclosures through third-party SDKs
Breach mitigation and forensic analysis of root causes need to be done quickly in order to mitigate the breach.
Validating Controls Through Auditing
The HIPAA audit control standard for covered entities dictates that they must “implement procedures to regularly review records of information system activity.”
Auditing considerations for mobile app PHI security include:
- Enabling detailed logging that captures all PHI transactions
- Periodically analyzing logs for improper data access
- Testing authentication and authorization controls
- Assessing encryption policies through static analysis
- Modeling attack scenarios to check controls
- Documenting all technical and administrative safeguards
Third-party auditors typically analyze logs, perform penetration testing, and formally certify that HIPAA-compliant controls are working properly.
Annual compliance audits should be conducted on the apps that handle PHI. Corrective action plans must be used to remedy identified risks.
Achieving Developer & Organizational Buy-In
Achieving a HIPAA-compliant mobile app is paramount and necessitates the involvement of an organization’s workforce, making HIPAA mobile app compliance goals reachable.
- Security left must be shifted from developers, and compliance must be prioritized from the start of the project
- Shared compliance goals should be worked on by the security and engineering teams closely
- Leadership must provide resources for robust PHI protections
- All staff interacting with PHI data must undergo regular HIPAA training
- Organizations could consider hiring dedicated resources focused on privacy and security
A genetic testing business called 23andMe paid $30 million to resolve a data breach claim in 2024. Because of poor security policies, the hack revealed personal information, including the genetic data of 6.9 million consumers. Along with cash reimbursements, the settlement covers three years of security monitoring for impacted consumers.
Take a strategic approach:
- Define all PHI data flows to mobile apps
- Create mobile app threat models, documenting risks
- Maintain HIPAA risk management plans
- Develop company-wide HIPAA policies and procedures
Integrating compliance into development workflows, processes, and culture is key.
Looking Ahead at HIPAA Mobile App Compliance
HIPAA mobile app compliance is multi-faceted regarding technical, administrative, and physical security; it is achievable and mandatory.
Since healthcare is increasingly becoming part of the digital age, HIPAA regulations will change to handle new attack sources. There will probably be stiffer safeguards to protect PHI on mobile devices.
Advancing compliance best practices include:
- Adopting privacy and security by design principles for all app development
- Contributing to industry standards, evolving mobile healthcare security
- Joining industry groups dedicated to advancing HIPAA-compliant practices
- Monitoring enforcement actions and breach cases to apply lessons internally
Securing PHI on mobile will present barriers, but innovative security frameworks aimed at healthcare ecosystems will facilitate developers’ compliance. Implementing multi-layer protection is centered on protecting patient data as healthcare transacts in the digital age.
Photo by Ashkan Forouzani; Unsplash
Kyle Lewis is a seasoned technology journalist with over a decade of experience covering the latest innovations and trends in the tech industry. With a deep passion for all things digital, he has built a reputation for delivering insightful analysis and thought-provoking commentary on everything from cutting-edge consumer electronics to groundbreaking enterprise solutions.
