Overview
This category is about auditing, which is a mechanism for user and system accountability. Important events, such as logins and access to particular functions and data, are recorded and can be used to detect instances of non-compliant behavior and to facilitate detection of improper creation, access, modification, and deletion of personal health information. Any information technology including consumer health apps should follow best practices in managing an audit trail. The audit trail should maintain a record of users who have accessed what data, from where, and when. Audit logs should also record any attempts to access the system from an unauthorized terminal; expired usernames or passwords that try to access the system, unusual numbers of authentication attempts, and violations of an organizations security policy.[1]
Related Regulations and Standards
Implementation Guidance
Every consumer mobile health app needs an audit strategy, which includes what data will be generated for audit, who will be able to access audit records, the location where audit data is stored, the length of time audit information will be stored, and any ability to delete audit data. Audit for security events is highly dependent on the nature of the app itself; audit requirements will differ significantly based on app sponsorship (e.g., sponsor is a HIPAA entity or a commercial non-covered entity), the need for user authentication, and if data generated through an app is accessible by consumers, clinicians, or both.
[1] NIST Security Architecture Design Process for Health Information Exchanges (HIEs): https://www.nist.gov/healthcare/security/health-information-exchange-hie-security-architecture