CMINDS

Computerized Multiphasic Interactive Neurocognitive DualDisplay System


Comprehensive Regulatory Compliance


By design, CMINDS® fully complies with all applicable regulatory agency requirements regarding the collection and management of clinical data, including the FDA's "Computer Systems Used in Clinical Research"; the Department of Health and Human Services (DHHS): 21 CFR Part 11 for Electronic Health Records and Electronic Signatures and the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

System functions and capabilities relevant to compliance with regulatory agency requirements are conferred by the following:

  1. A hierarchical password system
  2. Role-based access control (RBAC) and function-based access control (FBAC)
  3. Automatic program log-off
  4. Automatic password expiration
  5. Automatic database checksum (to corroborate that the database file has not been altered in any unauthorized manner)
  6. Database encryption
  7. Comprehensive audit log (records all relevant information pertaining to the Examiner's activities, including: date-stamped and time-stamped log-in, log-off; file access; and program operations)
  8. Automatic database backup to optical media, enabling off-site storage and rotation

Collectively, these features ensure highly controlled data access and full accountability.

CMINDS® has been developed in compliance with IEEE guidelines.