Guide to HIPAA Rules in the Compliance Center
This table defines the HIPAA rules covered in FileCloud's Compliance Center, explains what steps you must take to be in compliance, and describes how FileCloud validates each rule.
Rule (click to see text) | Description | Steps for complying | Validation |
---|---|---|---|
164.304 Definitions | Identify which files have electronically protected health information (ePHI). | In the Compliance Center, click the Edit button for the rule, and select a metadata set with a tag that identifies ePHI files. | If the metadata set exists and is enabled, status is OK; if not, status is Issues. |
164.306 Security standards: General rules | Allow at least one user access to the Compliance system. | To enable at least one user to manage the Compliance Center:
| If one or more Admin users have access to the Compliance Center, status is OK; if not, status is Issues. |
164.308 Administrative safeguards. (a)(1)(ii)(A & B) | Confirm that all the FileCloud Compliance HIPAA rules are successful. | Enable this rule once all the other HIPAA rules are compliant. | If all rules are implemented and status of all rules is OK then the status of this rule OK; if not, status is Issues. |
164.308 Administrative safeguards. (a)(1)(ii)(D) | Implement a procedure to regularly review system activity records. | In Settings > Admin, check Send Admin Governance Report Emails. | If the Send Admin Governance Report Emails setting is enabled, status is OK; if not, status is Issues. |
164.308 Administrative safeguards.(a)(3)(ii)(A) | Allow users to login to access FileCloud content based on location or IP address. | Click the Edit button and select a DLP rule that blocks users from logging in from outside locations. | If the DLP rule exists and is enabled and GeoIP is not disabled, status is OK; otherwise, status is Issues. |
164.308 Administrative safeguards.(a)(5)(ii)(B) | Configure Anti-Virus protection against malicious file uploads. |
| If an Anti-Virus is configured, status is OK; if not, status is Issues. |
164.308 Administrative safeguards.(a)(5)(ii)(C) | Monitor log-in attempts. |
| If Audit Logging Level is REQUEST or FULL status is OK; if Audit Logging Level is OFF, status is Issues. |
164.308 Administrative safeguards.(a)(5)(ii)(D) | Set up password management procedures. |
| If the password settings are configured as indicated, status is OK; if not, status is Issues. |
164.308 Administrative safeguards.(a)(6)(ii) | Confirm all (HIPAA) violations can be exported from the Compliance Center. | Enable this rule as confirmation that all FileCloud Compliance HIPAA violations can be exported. | None |
164.308 Administrative safeguards.(a)(7)(i) | Implement a contingency plan in case systems containing ePHI are damaged. | Enable this rule as confirmation that you have done the following:
| None |
164.308 Administrative safeguards.(a)(7)(ii)(B) | Establish procedures to restore loss of data. | Enable this rule as confirmation that admins understand the procedures to restore data given at Backing Up and Restoring FileCloud Server. | None |
164.308 Administrative safeguards.(a)(7)(ii)(C) | Establish an emergency mode operation plan. | Enable this rule as confirmation that admins understand that they can configure a firewall proxy rule to prevent access to FileCloud to protect ePHI. | None |
164.312 Technical safeguards.(a)(1) | Implement policies and procedures to only allow access to ePHI to people and programs with access rights. | To prevent data from being shared with unauthorized users:
| If Share Mode is Allow All Shares or any public shares exist, status is Issues. |
164.312 Technical safeguards.(a)(2)(i) | Assign a unique name and/or number to each user. | Enable this rule as a confirmation that all users have unique usernames. | None |
164.312 Technical safeguards.(a)(2)(iii) | Terminate sessions after a certain amount of time automatically. | To confirm automatic logoff of sessions:
| If Session Timeout is set to 0 or empty, status is Issues. |
164.312 Technical safeguards.(a)(2)(iv) | Implement encryption and decryption of ePHI. | To set up ePHI encryption:
| If storage is not fully encrypted, or any existing files are not fully encrypted, status is Issues. |
164.312 Technical safeguards.(b) | Set up audit controls. | To implement audit controls:
| If any of the audit settings is not set as specified, status is Issues. |
164.312 Technical safeguards.(c)(1) | Protect ePHI files from destruction. | To protect ePHI files and folders from deletion:
| If the retention policy exists and is enabled, status is OK; if not, or if modifications to the retention policy allow file or folder deletion, status is Issues. |
164.312 Technical safeguards.(d) | Verify user identity of people seeking access to ePHI. | To confirm that all users have individual FileCloud user accounts, enable this rule. | None |
164.312 Technical safeguards.(e)(1) | Guard against unauthorized access of ePHI that is being transmitted. | To guard against unauthorized access to ePHI:
| If the DLP rule exists and is enabled and there are no existing public shares, status is OK; if not, or if modifications to the rule allow public shares, status is Issues. |
164.312 Technical safeguards.(e)(2)(i) | Ensure that transmitted ePHI is not modified. | To confirm that users are educated about sharing permissions and folder level permissions, enable this rule. | None |
164.316 Policies and procedures and documentation requirements.(b)(2)(i) | Retain files for 6 years. | To retain files for 6 years:
| If the retention policy exists and is enabled, status is OK; if not, status is Issues. |
164.316 Policies and procedures and documentation requirements.(b)(2)(ii) | Make documentation available and accessible. | To confirm that Admins and users have access to support documentation for all features, enable this rule. | None |
164.316 Policies and procedures and documentation requirements.(b)(2)(iii) | Maintain updated documentation. | To ensure the system is at the latest version, go to Upgrade screen in Admin and ensure there are no upgrades available | If the system is not upgraded to the latest available version, then status is Issues. |
164.404 Notification to individuals. (b) | Create timely notifications in case of breaches. | To confirm that admins can use Audit logs, Alerts and Violation reports to generate breach notifications, enable this rule. | None |
164.502 Uses and disclosures of protected health information: General rules.(a)(1) | Allow users to use and disclose ePHI according to regulations. | To prevent data from being shared with non-associates without proper permission:
| If Share Mode is Allow All Shares or any public shares exist, status is Issues. |
164.504 Uses and disclosures: Organizational requirements.(e)(1) | Business associates must comply with standards. | To confirm that users who have access to ePHI are educated about sharing permissions, enable this rule. | None |
164.504 Uses and disclosures: Organizational requirements.(e)(2)(ii)(J) | At the termination of a contract, all info shared with business associate should be destroyed or returned. | To confirm return or destruction of ePHI at the termination of contracts:
| If all the settings are as specified, status is OK; if not, status is Issues. |
164.508 Uses and disclosures for which an authorization is required.(a) | Uses of ePHI requiring authorization. | To implement authorization for use and disclosures of ePHI:
| If the DLP rule exists and is enabled, status is OK; if not, or if modifications to the rule allow public shares, status is Issues. |
164.522 Rights to request privacy protection for protected health information. (a)(1) | Right of individual to request restriction of disclosure of their ePHI. | To implement the right of an individual to request restriction of uses and disclosures of ePHI:
| If Disable Locking is unchecked, status is OK; if not, status is Issues. |
164.528 Accounting of disclosures of protected health information. | Right of an individual to receive records of disclosures of PHI. | To confirm that admins understand how to use audit logs and reports to generate an account of disclosures of protected health information, enable this rule. | None |