HIPAA Breach Reporting Tips & Tricks IADDA Annual Conference 2014

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1 HIPAA Breach Reporting Tips & Tricks IADDA Annual Conference /3/14 Gerald Jud E. DeLoss

2 Disclaimer 2 o This presentation and its materials are for informational purposes only and not for the purpose of providing legal advice.

3 Learning Objectives 3 Identify a Breach Under HIPAA Determine Exceptions to HIPAA Breach Notification Requirements Identify General Obligations Under 42 CFR Part 2 Distinguish Between a HIPAA Breach and a Potential Violation of 42 CFR Part 2 How to Undertake a HIPAA Breach Risk Assessment Determine When to Provide HIPAA Breach Notification and to Whom

4 4 Final HIPAA Rule Breach Notification Provisions

5 HIPAA Breach Notification 5 What is and is Not a Breach Under HIPAA Expansion Under HIPAA Final Rule Include in Notice of Privacy Practices Presumption of Breach removed risk of harm standard Imposed upon Business Associates Maintains safe harbor for encryption Reporting obligations to: Client Subcontractor to Business Associate to Covered Entity Media HHS

6 HIPAA Breach Notification 6 What is a Breach? Unauthorized acquisition, access, use, or disclosure of PHI that compromises the privacy or security of the PHI Impermissible use or disclosure of PHI is presumed to be a breach

7 HIPAA Breach Limitations 7 Presumed a Breach, Unless Demonstrate That There is a Low Probability that the PHI Has Been Compromised Through Risk Assessment Covered Entities or Business Associates Have Burden of Proof That Not a Breach Breach Only if Violation of HIPAA Impermissible use or disclosure only under Privacy Rule not other law If HIPAA permits the use or disclosure, then not considered a Breach

8 HIPAA Not a Breach 8 What is Not a Breach? Low probability that PHI has been compromised using a risk assessment: Evaluate nature and extent of PHI involved Behavioral health information Financial information Recipient of the PHI Obligated to maintain privacy and security Ability to determine identities of individuals Actual acquisition or viewing of the PHI Was information actually acquired or seen Mitigation of risk to PHI

9 9 HIPAA Breach Notification Exceptions What is Not a Breach? Unintentional acquisition, access or use of PHI by a workforce member or person acting under authority of covered entity or business associate if in good faith and within scope of authority, with no further use or disclosure Inadvertent disclosure by authorized person at a covered entity/business associate to another authorized person at the covered entity/business associate, with no further use or disclosure Disclosure where there is good faith belief that unauthorized recipient would not reasonably have been able to retain the PHI

10 HIPAA Breach Encryption 10 What is Not a Breach? PHI that is secured Rendered unusable, unreadable, or indecipherable through use of technology or methodology Encryption safe harbor

11 Notice of Privacy Practices 11 Under Final Rule, Notice of Privacy Practices Must Reference Breach Notification Not Necessary to Provide Detailed Description Simply referencing obligation to notify patient of Breach is sufficient

12 Notification to Patient 12 Covered Entity Must Notify Patient Within 60 Days of Discovery of Breach Deemed discovered when person other than person committing the Breach knows or reasonably should have known of the Breach Limited exception when law enforcement requests a delay in notification Cannot wait until investigation is completed Cannot simply wait 60 days if know it is Breach before that time

13 Notification To Patient 13 Process of Breach Notification to Patient Notice must be provided via US Mail If patient agrees and requests notice, you may provide notice Where out-of-date contact information for fewer than 10 patients, may provide telephonic notice For 10 or more patients, substitute notice: Posting general notice on website for 90 days Toll free number available for 90 days If urgent due to imminent misuse, then telephone

14 Notification to Patient 14 Substance of Breach Notification Brief description of what happened, including date of Breach and discovery Types of PHI involved Any steps patients should take to protect themselves Brief description of what you are doing to investigate, mitigate, and prevent future risks Contact information

15 Notification to the Media 15 Breaches Involving More Than 500 Residents of State or Jurisdiction Require Notice to Media Outlets Also within 60 days of discovery Substance of notice is the same as to the patient Posting to your website is not sufficient Press release to prominent media outlets allowed

16 Notification to HHS/OCR 16 Breach Notification Required to HHS/OCR Breaches of less than 500 patients require notice to HHS within 60 days following conclusion of calendar year Breaches of 500 or more patients require immediate notice Within 60 days of discovery HHS posts to its website Note that media notice is for more than 500 and notice to HHS/OCR is 500 or more

17 Notification By Business Associate 17 Business Associates Obligated to Provide Timely Notice Notice is to covered entity, not patient unless agreement specifies Notice must be within 60 days Note that if business associate notifies covered entity on 60 th day, may not be time for covered entity to comply and notify patient Subcontractors of business associates notify next upstream entity

18 18 42 CFR Part 2 Federal Regulations on Confidentiality of Alcohol and Drug Abuse Patient Records

19 42 CFR Part 2 19 General Requirements Authorization required for disclosure to most third parties No Treatment, Payment and Healthcare Operations exception like under HIPAA Disclosure to Qualified Service Organization ( QSO ) Similar to HIPAA business associate

20 42 CFR Part 2 20 Criminal Law Prohibition on Redisclosure Disclosure Limited to Identified Recipients Impacts Upon Health Information Exchange

21 42 CFR Part 2 21 NO Breach Reporting Requirement Only HIPAA Imposes a Breach Reporting Obligation Not Every Violation of Part 2 Will Amount to a HIPAA Breach

22 22 Intersection of HIPAA and 42 CFR Part 2 Breach Reporting Obligations and Exceptions

23 Intersection of HIPAA and Part 2 23 Breach Only if HIPAA is Violated Violation of 42 CFR Part 2 not necessarily a Breach If impermissible use or disclosure due only to limitations imposed under Part 2, then may not need to report a Breach Separate obligations may arise under Part 2

24 Intersection of HIPAA and Part 2 24 Area of Concern Under HIPAA for Violations of Part 2 Incident considered a Breach where violation of minimum necessary standard HIPAA minimum necessary standard prevents use or disclosure of PHI beyond that which is reasonably necessary to carry out the relevant duty or task Minimum necessary does not apply to Treatment Express restrictions on use of entire medical record Minimum necessary is defined in covered entity s policies important to carefully define!

25 25 Analyzing Part 2 and HIPAA Breach Reporting Requirements Reference HIPAA Breach Exceptions: Unintentional acquisition, access or use of PHI by a workforce member or person acting under authority if in good faith and within scope of authority, with no further use or disclosure Inadvertent disclosure by authorized person to another authorized person, with no further use or disclosure Disclosure where there is good faith belief that unauthorized recipient would not reasonably have been able to retain the PHI

26 Part 2 and Breach Exceptions 26 Unintentional Acquisition, Access or Use of PHI by a Workforce Member or Person Acting Under Covered Entity/Business Associate Authority Employee has authority but accidentally accesses wrong PHI Possibly a violation of Part 2 if staff member not authorized to access that particular client s record Not likely a Breach because exception applies

27 Part 2 and Breach Exceptions 27 Inadvertent Disclosure by Authorized Person at Covered Entity or Business Associate to Another Authorized Person at Same Covered Entity or Business Associate, With No Further Use or Disclosure Example might be disclosure from staff in a SUD facility to a co-worker who works in non-sud department of a healthcare system Disclosure might be violation of Part 2 but not likely a Breach

28 Part 2 and Breach Exceptions 28 Disclosure Where There Is Good Faith Belief That Unauthorized Recipient Would Not Reasonably Have Been Able To Retain The PHI Establish that recipient did not access PHI Establish that recipient could not have stored or shared PHI Example: unopened envelope Likely violation of Part 2 if recipient unauthorized and viewed the information but not necessarily a Breach if did not retain

29 Part 2 and Breach Risk 29 Assessment HIPAA Also Does Not Require Breach Notification if Risk Assessment Establishes Low Probability That PHI Compromised Example: When a covered entity sends a fax to the wrong healthcare provider If recipient is notified and destroys PHI Possibly a Part 2 violation if sent to unauthorized healthcare provider Not likely a Breach based upon low risk

30 30 Real World Examples Time to Play Breach or No Breach?

31 Example #1 31 SUD Provider Faxes Correct Client but Wrong Information to Plan for Authorization PHI relates to client who has not executed consent for release for the specific type of information that was included Client executed consent for only certain information to be disclosed Breach or No Breach?

32 Example #1 - Answer 32 This Scenario Represents a Low Probability That the PHI was Compromised Based Upon Risk Assessment Involves two covered entities, each bound by HIPAA Likely Not a Breach Provider must take steps to ensure plan returns/destroys PHI Mitigation efforts Counter-argument that violates minimum necessary standard However, risk assessment establishes not a Breach

33 Example #2 33 SUD Provider Faxes Wrong Client Information to Physician s Office PHI relates to client who has not executed consent for release Breach or No Breach?

34 Example #2 - Answer 34 This Scenario Represents a Low Probability That the PHI was Compromised Likely Not a Breach Provider must take steps to ensure physician s office returns/destroys PHI Mitigation efforts Counter-argument that violates minimum necessary standard However, risk assessment establishes not a Breach

35 Example #3 35 Clinician Accidentally Accesses PHI of Client With Whom She/He Does Not Have a Treatment Relationship Clinician generally has authority to access files at the facility, just not this particular client Breach or No Breach?

36 Example #3 - Answer 36 This Scenario Relates to an Unintentional Access of PHI by a Workforce Member Who Has Authority to Access PHI at the Facility Access was within the scope of his/her authority Access must have been made in good faith Must not result in further use or disclosure Likely not a Breach

37 Example #4 37 SUD Facility Staff Accidentally Faxes PHI of Client to Wrong Recipient For example, sends PHI to entity with similar sounding name but is not correct recipient Breach or No Breach?

38 Example #4 - Answer 38 This Scenario May or May Not be a Breach If provider immediately contacts the recipient and notifies the individual to return/destroy the fax If recipient is a covered entity, not likely a Breach If recipient is not a covered entity, may still not be a Breach If PHI is destroyed and not accessed, used or disclosed Low risk of compromised PHI utilizing risk assessment

39 Example #5 39 SUD Facility s PHI Directly to Client Using Unencrypted System PHI is sent without any protection: password, encryption, etc. Client receives the PHI Breach or No Breach?

40 Example #5 - Answer 40 Even Though Not Encrypted, if Client Requests PHI to be ed, Then She/He Assumes the Risks and Would Not be Considered a Breach Covered entities are permitted to send PHI to clients if they have advised the client of the risk and the client still desires to receive the PHI in that form Practice tip: create Authorization Form

41 Conclusion 41 o o o Take Steps to Identify What is and What is Not a Breach o Exceptions o Risk assessment Remember Not Every Part 2 Violation Equals a HIPAA Breach Breach Notification Requirements o Client o Media o HHS

42 Questions? 42 Gerald Jud E. DeLoss Tel Fax

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