ComplianceOnline

HIPAA - Business Associate Contract


The HIPAA Rules that covered entities and business associates enter into contracts to ensure that the business associates will appropriately safeguard protected health information. The business associate contract also serves to clarify and limit, as appropriate, the permissible uses and disclosures of protected health information by the business associate, based on the relationship between the parties and the activities or services being performed by the business associate

Agreement need to be between Covered Entities and Business Associates and between BAs and their subcontractors.

Agreement Not required with:
  • Payers or other providers
  • Workforce members
  • Conduits (USPS, FedEx, etc.)
  • No requirement to monitor BAs, but need to receive assurances
  • No BA needed if no access to or maintenance of PHI
  • Technical support services may need access to PHI (including systems, software, fax/copiers, etc.)
Key elements of agreement between covered entity and BA:
  • Signatures, Start/Expiration/Review Dates
  • Terms & Conditions (incl. how to use or disclose PHI, data rights, minimum security)
  • Recording and Reporting Breaches
  • Penalties for Breaches
  • P&P for Data Retention and Destruction
  • Subcontractors Held to Same Standard
Business Associate Agreement Provisions:
  • Establish permitted and required uses of PHI
  • Require the BA not to use or disclose PHI other than as allowed under the BAA or by law
  • Require the BA to use appropriate safeguards and comply with applicable privacy and security rules
  • Require the BA to report to CE any unauthorized uses or disclosures of PHI, including breaches of unsecured PHI
  • Require BA to comply with any HIPAA privacy rules applicable to the relationship between the BA and CE
  • Special provisions based on roles
    • Breach notification - timing, evaluation, process
    • Restrictions on certain disclosures
    • Restrictions on marketing, fund raising and sale of PHI
    • Accounting of disclosures
    • Individual right of access to electronic PHI
    • Minimum necessary and use of limited data set
    • Subcontractor provisions
Key facts about Agreement between Business Associate and sub-contractor
  • As per the new rules contractors are now BAs so they must be under contract requiring similar protections and compliance as the BA
  • Contract should include rights of review of security, provision of evidence of good practices
  • Contract should specify privacy and security practices and they should be prepared to implement better security, secure communications, storage
  • "Agency" relationship rules also apply to BA-subcontractor relationships
    • If BA is an Agent, Covered Entity is responsible for BA's actions performing HIPAA obligations, BAA or not
    • If BA is an Agent, Covered Entity's clock on Breach Notification begins upon discovery by the BA
    • If BA is not an Agent, Covered Entity's clock begins upon notice by the BA