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HIPAA, HITECH & HIT Legal Issues, Developments and Other Pertinent Information Relating To The Creation, Use and Exchange of Electronic Health Records

Sixty Days or Sixty Minutes – What is Your Breach Reporting Deadline?

Posted in Health Reform, Security Breach Notification

If you are a federally-facilitated health insurance exchange (FFE), a “non-Exchange entity”, or a State Exchange, the answer is “Quick, report!”  Those involved with the new health insurance exchanges (or “Marketplaces”?  The name, like the rules, seems to be a moving and elusive target) should make note that privacy and security incidents and breaches are to be reported within one hour of their discovery, according to regulations proposed by the Department of Health and Human Services (HHS) on June 19, 2013 (“Exchange Regulations”).  That’s right – within one hour, or a measly 60 minutes, of discovery of a breach involving personally identifiable information (PII), the entity where the breach occurs must report it to HHS.  Even a mere security “incident” would have to be reported within one hour.  The broad term “incident” would include:

[t]he act of violating an explicit or implied security policy, which includes attempts (either failed or successful) to gain unauthorized access to a system or its data, unwanted disruption or denial of service, the unauthorized use of a system for the processing or storage of data; and changes to system hardware, firmware, or software characteristics without the owner’s knowledge, instruction, or consent. 

Whereas HIPAA breaches (those involving protected health information, or PHI) affecting more than 500 individuals must be reported to HHS “without unreasonable delay and in no case later than 60 days after discovery” and (as discussed here in an earlier blog post) there is no express requirement for reporting of security incidents to HHS , HHS’s new proposal requires a 60-minute turn-around for PII breaches and incidents alike.  HHS says that it “considered but declined to use the definitions” for “incident” and “breach” provided under the HIPAA regulations because “the PHI that triggers the HIPAA requirements is considered a subset of PII, and we believe that the HIPAA definitions would not provide broad enough protections… .” 

The 60-minute turnaround time may sound familiar to Medicare Shared Savings Programs (MSSPs, also known as Medicare Accountable Care Organizations or ACOs).  Approved MSSPs must sign a Data Use Agreement with the Centers for Medicare & Medicaid Services (CMS) before it can obtain data from CMS that contains Medicare beneficiaries’ PHI.  The 60-minute turnaround under the Data Use Agreement is even a bit more onerous than that proposed in Exchange Regulations in that breaches of PII must be reported within 60 minutes of the breach, loss, or unauthorized disclosure itself, rather than within 60 minutes of discovery of the breach, loss, or unauthorized disclosure.  Then again, the Data Use Agreement doesn’t require reporting of “incidents” like attempted access or power interruptions, and CMS is thoughtful enough to provide a phone number and email address to be used in making the reports.