A Panel Discussion. Nancy Davis
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1 A Panel Discussion 1 Nancy Davis Director of Compliance & Safety, Door County Medical Center Cathy Hansen Director, Health Information Services & Privacy Officer, St. Croix Regional Medical Center Rhonda Joseph Compliance & Privacy Manager Corporate Compliance, Froedtert Health Tennille Sifuentes Director Corporate Compliance, Medical College of Wisconsin Meghan O'Connor Partner and Milwaukee Office Chair of Health & Life Sciences Practice Group, Quarles & Brady LLP 2 Brief Summary of HIPAA Breach Requirements Risk Assessments Big Breaches Breach Notification Corrective Action Audience Participation (As Time Allows) Business Associates Technology and Increased Risk 3 1
2 A Brief Summary 4 An acquisition, access, use, or disclosure of PHI impermissible under the Privacy Rule that compromises the security or privacy of the PHI Presumed to be a breach unless the entity demonstrates there is a low probability that the PHI has been compromised based on a risk assessment Discretion to skip risk assessment and move right to providing notification 5 Low probability of compromise risk assessment must include, at a minimum, the following four factors: Nature and extent of the PHI involved, including the types of identifiers and likelihood of reidentification Unauthorized person who used the PHI or to whom the disclosure was made Whether the PHI was actually acquired or viewed The extent to which the risk to the PHI has been mitigated 6 2
3 Unintentional acquisition, access, or use of PHI by workforce member if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under Privacy Rule. Inadvertent disclosure by a person who is authorized to access PHI to another person authorized to access PHI at the same entity or OHCA, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under the Privacy Rule. Disclosure of PHI where entity has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information 7 Breach notification required if breach involved unsecured PHI Unsecured PHI is PHI that has not been rendered unusable, unreadable, or indecipherable to unauthorized persons through use of technology or methodology specified by HHS Secretary Encrypted at rest (NIST SP ) and in motion (NIST SP , NIST SP , or FIPS validated) 8 Without unreasonable delay and in no case later than 60 calendar days after discovery of breach of unsecured PHI "Discovered" as of first day on which breach is known, or by exercising reasonable diligence, would have been known Deemed knowledge of breach if known, or by exercising reasonable diligence, would have been known to any person (workforce member or agent) other than the person committing the breach 9 3
4 Written form, plain language First-class mail, or by if affected individual has agreed Substitute notice option if insufficient or out-ofdate contact information that precludes written notification Fewer than 10 individuals: Alternative form of written notice, phone, or other means 10 or more individuals: Conspicuous website posting for at least 90 days or major print/broadcast media in affected geographic area with toll-free number active for 90 days Additional phone/other notice in urgent situations because of possible imminent misuse of PHI 10 Brief description of what happened, including date of the breach and date of the discovery of the breach, if known Description of the types of unsecured PHI involved Any steps individuals should take to protect themselves from potential harm resulting from breach Brief description of what the entity involved is doing to investigate the breach, mitigate harm to individuals, and protect against any further breaches Contact procedures for individuals to ask questions or learn additional information, which shall include a tollfree telephone number, an address, website, or postal address 11 Fewer than 500 Individuals: May report any time, but report must be submitted within 60 days of the end of the calendar year in which the breach was discovered Notice submitted electronically via OCR portal 500 or more Individuals: Without unreasonable delay and in no case later than 60 calendar days from discovery of breach Notice submitted electronically via OCR portal Posted on "Wall of Shame" 12 4
5 If breach affects more than 500 residents of a state or jurisdiction, notice must be provided to prominent media outlets Without unreasonable delay and in no case later than 60 days following discovery of breach Must include same information as individual notice 13 Panel Discussion 14 Process / Workflow RA Tools Vendor tool or self-designed Documentation / Maintaining consistency Reporting / Tracking key indicators 15 5
6 Panel Discussion 16 Discovery Who Roles and Responsibilities of User(s) How Was PHI Accessed Containment Change Usernames and Passwords Communications Rapid Assessment Assess Scope Report to Insurer? (Beazley) Retain Outside Legal Counsel? Forensics Internal vs. External Review What systems and data How long was PHI vulnerable Amount and type of PHI Patients Impacted Identify Exact Patients and PHI Link to Demographics (Reg, Cognos) Duplicates, Missing Data Communicate with FH and CHW Notifications Establish Call Center Patients OCR MCW Employees; Board of Trustees Media Press Release Post Incident Patient Communications OCR Investigation 17 8 individuals 133,500 total s 15,000 flagged as possible PHI 2,000 attachments required manual review 10,619 patients identified; 1,159 duplicates 9,460 patients final 1,425 unidentified (no match, incomplete match) 8,035 identified and letters sent 34 w SSN; 1 with Financial Information 119 Calls to Call Center; 14 Escalated to Compliance 18 6
7 Panel Discussion 19 Communicating with affected individual(s) Individual notification letter language Include the names of the bad actor(s)? Responses from affected individuals? Small community factors 20 Panel Discussion 21 7
8 Level 1 Minor issue or issue due to carelessness For example: Talking loudly about a patient where others can hear Faxing to an incorrect location Leaving workstation without securing it Sending PHI electronically without appropriate safeguards (failing to encrypt ) 22 Level 2 Intentional inappropriate use, disclosure and/or access (without a legitimate business reason), but without malice For example: Accessing PHI of a family member who has given permission, but no signed authorization on file Sharing a password with a co-worker who forgot theirs 23 Level 3 Intentional use, access and/or disclosure with malice or with reckless disregard to consequences For example: Accessing PHI out of curiosity Accessing PHI of a co-worker to see why the coworker was in the medical center for care Intentional, unauthorized release of PHI Destroying, stealing, or tampering with records 24 8
9 Breach Level Re- Education Verbal Warning Written Warning Suspension/Last Chance Agreement Termination of Employment Level 1 1 st Offense R O 2 nd Offense R X O 3 rd Offense R X O 4 th Offense X O Level 2 1 st Offense R O X O 2 nd Offense R X O 3 rd Offense X Level 3 1 st Offense X 25 Length of employment Is this a good employee? History of other corrective action Prior HIPAA violation(s)? If so, what? Level of corrective action assigned Does the individual understand the seriousness of the offense? Other mitigating factors 26 Who makes the decision? Formal Coaching/Re-education Privacy Officer, Department Director Verbal Warning Privacy Officer, Department Director Written Warning Privacy Officer, Department Director, Human Resources Suspension Privacy Officer, Department Director, Human Resources Termination Privacy Officer, Department Director, Human Resources Working together: facility & medical group 27 9
10 Audience Participation 28 How do you handle reporting? BA report to affected individuals, OCR, and/or media? Consistent stance or case-by-case decision? Is reporting process outlined in your BAA? How do you control messaging to minimize PR hit? When reporting is done, what next steps do you think about? Revisit BAA? Initiate performance plan? Require ongoing compliance reporting? 29 How are you balancing providers' and patients' increased interest in using technology for communication (e.g., text, , photos, etc.) with privacy and security concerns? 30 10
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