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Legal Disclaimer

The existence of a link or organizational reference in any of the following materials should not be assumed as an endorsement by Clearwater Compliance LLC.

This information does not constitute legal advice and is for educational purposes only. This information is based on currentfederal law and subject to change based on changes in federal law or subsequent interpretative guidance. Since this information is based on federal law, it must be modified to reflect state law where that state law is more stringent than thefederal law or other state law exceptions apply. This information is intended to be a general information resource regarding the matters covered, and may not be tailored to your specific circumstance. YOU SHOULD EVALUATE ALL INFORMATION, OPINIONS AND RECOMMENDATIONS PROVIDED HEREIN IN CONSULTATION WITH YOUR LEGAL OR OTHER ADVISOR, AS APPROPRIATE.

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How to Prepare For An OCR Audit Or Investigation

July 14, 2016


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About Your Speaker

Michelle [email protected]

Michelle Caswell, Senior Director Legal & Compliance | JD• More than 15 years healthcare experience• Extensive experience in HIPAA Privacy, Security and Breach Notification Rules• Former HIPAA Investigator for the U.S. Department of Health and Human Services, Office

for Civil Rights• Experienced Principal Healthcare Privacy/Security Consultant, conducting compliance

audits and risk assessments; drafting policies and procedures; training staff and assisting with remediation efforts

• Licensed attorney in Georgia and Tennessee• Frequent national speaker on healthcare compliance and security

mailto:[email protected]


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Our Passion

We’re excited about what we do because…

…we’re helping organizations improve patient safety and the quality of care by safeguarding the very personal and private healthcare information of millions of fellow Americans…

… And, keeping those same organizations off the Wall of

Shame…!


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Bottom Line Up Front

Clearwater Compliance – A Better, Brighter Idea!

Highly Reference-able Hospital / Health System Customer Base, with Exclusive AHA Endorsement

Commercially Competitive Professional Services Fees

Proven Experience in Large Complex Healthcare

Environments

Independent, Objective Advisory Services with

No Vendor Ties

Deep Experience with (36+) Organizations Audited by

OCR, CMS & OIGBusiness Risk Management focus While Achieving Regulatory Compliance

Seasoned Professionals in Healthcare Privacy, Security, Compliance & Information Risk Management

Significant Post Breach Experience and Partner Network


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Awards and Recognition

2015 & 2016

Exclusive

Industry Resource Provider

Software Used by NSA/CAEs

Sole Source Provider

#11 – 2015 & 2016


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Our Goal Is To Help You Become As Self-Sufficient As You Wish To Be

This empowering philosophy underpins everything we do. Commitment to educational resources for our

audiences Ongoing support and training for our customers Thought-, service-, methodology- and software-

leadership


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Some Ground Rules1. Slide materials2. Questions in “Question Area” on GTW

Control Panel3. In case of technical issues, check “Chat

Area”4. All Attendees are in Listen Only Mode5. Please complete Exit Survey, when you

leave session6. Recorded version and final slides within 48

hours


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We are not attorneys! Ensure Competent Counsel

The Omnibus has arrived!Welcome Aboard, BAs!

Lots of different interpretations! Please, Ask Lots of Questions!

But FIRST!


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Overview

“How to Prepare for an OCR Audit or Investigation”

Instructional Module Duration = 75 Minutes

1. Why Bother to Prepare?2. Where are the Gaps in Compliance?3. What to do About It?

Learning Objectives Addressed in This Module:


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1. Why Bother To Prepare


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What type of organization do you represent?

Hospital / Health System

Other CE

Business Associate

HybridDon’t Know

Pause and Quick Poll


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Three Pillars Of HIPAA Compliance…

HITECH

HIPAA

Privacy Rule• 75 pages / 27K words• 56 Standards• 54 Implementation Specs

Security Rule• 18 pages / 4.5K words• 22 Standards• 50 Implementation Specs

Breach Notification 6 pages / 2K words• 4 Standards• 9 Implementation Specs

OMNIBUS FINAL RULE


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Key Audit Inquiry2012

1. Inquire of management as to whether formal or informal policy and procedures exist

2. Obtain and review formal or informal policy and procedures

3. Evaluate the content in relation to the specified performance

4. Determine if the covered entity's formal or informal policy and procedures have been approved and updated on a periodic basis.

20161. Does the entity have policies and

procedures in place? 2. Determine how the entity has

implemented the requirements3. Obtain and review documentation

demonstrating that policies and procedures have been implemented

4. Evaluate and determine if practices are handled in accordance with the related policies and procedures

5. Elements to review may include…


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Do Your Homework…

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol-current/index.html




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Phase 2 Audits: Current Audit Protocol• As of July 11, 2016, 167 health plans, health care providers and

clearinghouses were notified of desk audits• Chosen organizations received 2 emails

1. Notification letter, timeline for response and unique link to submit via OCR’s online portal

2. Additional request to provide a listing of the entity’s BAs, and information re: an upcoming OCR webinar to explain the desk audit process

• All documentation must be current as of the date of the request• Entities have 10 business days, until July 22, 2016, to respond to

the document requests• Critical that documentation accurately reflects the program• Desk audits of business associates will follow this fall

One Shot! Best Be Super Ready


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Requirements Selected for Desk Audit Review

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html


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OCR’s Portal


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Document Request

Days Remaining to Submit Information


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Practice!

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol/index.html

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol/index.html


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And It’s Not Just The Audits… What About Complaints?

From 2013-2014 –increase of 4,805 complaints per year!


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Look How Easy It Is


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Sample Data Request Letter


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HIPAA Complaint

??

1.Complaint

2.Breach Notice

3.SAG HITECH Action

4.FTC Action

5.Whistleblower

6.State Action (e.g., DHCS)

7.OCR Audit

http://www.hhs.gov/ocr/privacy/hipaa/enforcement/process/index.html

Avoid the following…

Complaint

Intake & Review

Possible Privacy Rule or Security Rule Violation

Possible Criminal Violation

InvestigationResolution

• OCR finds no violation

• OCR voluntary compliance, corrective action, or other agreement

• OCR issues formal finding of violation

RESOLUTION

• The violation did not occur after April 14, 2003

• Entity is not covered by the Privacy Rule

• Complaint was not filed within 180 days and an extension was not granted

• The incident described in the complaint does no violate the Privacy Rule

DOJ Accepted by DOJ

http://www.hhs.gov/ocr/privacy/hipaa/enforcement/process/index.html


And, Please Do Not Forget OIG’s “Internal Audit” Role

Strengthen your

Oversight

http://oig.hhs.gov/oei/reports/oei-09-10-00510.asp

http://oig.hhs.gov/oei/reports/oei-09-10-00511.asp


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2. Where Are The Gaps in Compliance


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And, then there were 37…


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HHS “Wall Of Shame”

7.9%

• Inadequate workforce access controls

• Inadequate policies & procedures

• Inadequate training• Inadequate or inconsistent

sanctions• Inadequate safeguards (e.g.

disposal)


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Complaints… What Are People Saying?

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/data/top-five-issues-investigated-cases-closed-corrective-action-calendar-year/index.html

http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/data/top-five-issues-investigated-cases-closed-corrective-action-calendar-year/index.html


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Who’s Responsible?


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Who’s to Blame?

Case Examples• Access• Authorizations• Confidential Communications• Disclosures to Avert a Serious Threat to Health or Safety• Impermissible Uses and Disclosures• Minimum Necessary• Safeguards

Common Causes• Theft of Laptop, Servers, Backup Tapes, Mobile

Devices• Loss of Laptop, Servers, Backup Tapes, Mobile

Devices• Improper Disposal • Misdirected Communications• Post to Public Websites• Missing Firewalls• Successful Phishing

hhttp://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html


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Covered Entities On “Wall of Shame”

• Hospitals• Community Clinics• Specialty Clinics• Mental Health Clinics• State Health Plans• Private Practices• Research Organizations• Medical Centers

• Life Insurance• Emergency Responders• Health Systems• Health Plans• Employee Health Plans• Dental Practices• Physician Networks• University

Clinics/Hospitals


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Business Associates On “Wall of Shame”

• Consultants• Plan Administrators• Social Services• Transcription Companies• Collection Services

• Medical Management• Revenue Cycle Mgmt• Disease Management• Outsourced Computing• Other CEs


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3. What To Do About It?


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Safeguards – Administrative Requirements § 164.530(c)(1) Standard: Safeguards. A covered entity must have in place appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information.(2) (i) Implementation specification: Safeguards. A covered entity must reasonably safeguard protected health information from any intentional or unintentional use or disclosure that is in violation of the standards, implementation specifications or other requirements of this subpart.

(ii) A covered entity must reasonably safeguard protected health information to limit incidental uses or disclosuresmade pursuant to an otherwise permitted or required use or disclosure.


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Safeguards – Audit Procedures

• Has the covered entity implemented administrative, technical, and physical safeguards to protect all PHI from any intentional or unintentional use or disclosure that is in violation of the standards, implementation specifications or other requirements of this subpart?

• Does the covered entity reasonably safeguard protected health information to limit incidental uses or disclosures made pursuant to an otherwise permitted or required use or disclosure?

• Obtain and review policies and procedures to determine if appropriate administrative, technical, and physical safeguards are in place.

• Obtain and review documentation of specific safeguards in place from all three categories to reasonably protect the PHI. Such documentation may include, but is not limited to, policies and procedures, photographic or documentary documentation of physical and technical safeguards, and statements from privacy and security officials.


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Mitigation – Administrative Requirements § 164.530(f)

(1) A covered entity must mitigate, to the extent practicable, any harmful effect that is known to the covered entity of a use or disclosure of protected health information in violation of its policies and procedures or the requirements of this subpart by the covered entity or its business associate.


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Mitigation – Audit Procedures• Does the covered entity mitigate any harmful effect that is known to the covered

entity of a use or disclosure of PHI by the covered entity or its business associates, in violation of its policies and procedures?

• Obtain and review policies and procedures in place for consistency with the established performance criterion. Determine whether a process is in place to ensure mitigation actions are taken pursuant to the policies and procedures.

• From a population of instances of non-compliance within the audit period, obtain and review documentation to determine whether mitigation plans were developed and applied pursuant to the policies and procedures. [Note: OCR is not looking for violations in order to take enforcement action; we are restricting our analysis to whether appropriate mitigation plans consistent with the entity policies have been developed and applied]

• Obtain and review documentation that the policies and procedures are conveyed to the workforce.


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Workforce Access To PHI – Minimum Necessary § 164.514(d)(2)

Standard: minimum necessary requirementsi. A covered entity must identify:

A. Those persons or classes of persons, as appropriate, in its workforce who need access to protected health information to carry out their duties; and

B. For each such person or class of persons, the category or categories of protected health information to which access is needed and any conditions appropriate to such access.

ii. A covered entity must make reasonable efforts to limit the access of such persons or classes identified in paragraph (d)(2)(i)(A) of this section to protected health information consistent with paragraph (d)(2)(i)(B) of this section.


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Workforce Access To PHI – Audit Procedures• Has the covered entity implemented policies and procedures consistent with the

requirements of the established performance criterion to identify need for and limit use of PHI?

• Obtain and review policies and procedures for limiting access to PHI. Elements to consider include, but are not limited to:-

• Criteria for determining what level of access a person or class of persons will need• Criteria for modifying, reviewing, or terminating an individual’s access• Efforts to limit access consistent with the needs and conditions described for each

person or class of persons• Whether the policies and procedures take into account access to both PHI and ePHI.

• Obtain and review the access of a sample of workforce members with access to PHI for their corresponding job title and description to determine whether the access is consistent with the policies and procedures.

• NOTE: The rule requires that the class/job functions that need to use or disclose PHI be determined and the information be limited to what is needed for that job classification.


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Workforce Access Work Sheet• System/Application/Database• Data Description• Data Type (e.g. sensitive) or Data Classification• Functional Access• Department Access • Purpose of Access• Job Titles/Job Codes with Access• Management Authorization for Access

Initiation or Termination


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Sanctions – Administrative Requirement § 164.530(e)(1) Standard. A covered entity must have and apply appropriate sanctions against members of its workforce who fail to comply with the privacy policies and procedures of the covered entity or the requirements of this subpart.

(2) Implementation specification: Documentation. As required by paragraph (j) of this section, a covered entity must document the sanctions that are applied, if any.


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Sanctions – Audit Procedures

• Does the covered entity apply appropriate sanctions against members of the workforce who fail to comply with the privacy policies and procedures of the entity or the Privacy Rule?

• Obtain and review policies and procedures to determine if the entity has and applies sanctions consistent with the established performance criterion.

• Obtain and review documentation of the application of sanctions to a sample of workforce members to determine whether appropriate sanctions were applied. (Note: OCR is not looking for violations in order to take enforcement action; we are restricting our analysis to whether appropriate sanctions consistent with the entity policies have been applied.)


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Tiered Approach to Sanctions

• Nature of the incident informs severity of sanctions:

• Was the violation unintentional? Or Intentional?• What was the motivation?• Was this the employee’s first violation?• What was the content of the PHI disclosed?• Was there further disclosure or not?• What was done to mitigate further disclosure?

• Examples of Sanctions• Additional Training or Counseling• Verbal Warning• Note in Personnel File• Suspension without Pay• Reassignment or Demotion• Termination

Maintain sufficient flexibility in your Policy to allow for undefined situations

Apply consistently


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Complaints – Administrative Requirements §164.530(d)(1)-(2)

1. Standard. A covered entity must provide a process for individuals to make complaints concerning the covered entity’s policies and procedures required by this subpart and subpart D of this part or its compliance with such policies and procedures or the requirements of this subpart or subpart D of this part.

2. Implementation specification: Documentation of complaints. As required by paragraph (j) of this section, a covered entity must document all complaints received, and their disposition, if any.


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Complaints – Audit Procedures

• Has the covered entity documented all complaints received and their disposition consistent with the performance criteria?

• Obtain and review a sample of documentation of complaints for consistency with the established performance criterion.

• Has the covered entity documented all complaints received and their disposition consistent with the performance criteria?

• Obtain and review a sample of documentation of complaints for consistency with the established performance criterion.


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Reporting And Responding To Complaints

No Intimidation or Retaliatory Acts

Accept Complaints Investigate Resolution Respond Document

Determine For Each: Who, How, When, Resolution


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OCR Complaint Insider Tips

• If you receive a complaint, do due diligence and investigate allegations

• Keep written records• Make contact with your OCR investigator• Know where your policies and procedures reside• Read the complaint thoroughly• Respond to each request in the data request letter• Even if you do not have something in place, say that and show

other ‘reasonable and appropriate’ safeguards


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• If you have questions, or need technical assistance, reach out to your investigator

• Remember, OCR does not represent the Complainant• If you need additional time to respond to the Complaint,

request that from your investigator• Don’t wait until the last minute


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• When drafting your response, keep everything in numbered order, per the data request letter

• Don’t staple every individual item• Follow up once you submit your response to ensure delivery• If you haven’t heard from your investigator for awhile once

you have already confirmed delivery, follow up• But be aware, there are a very limited amount of investigators


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Clearwater HIPAA and Cybersecurity BootCamp™

Take Your HIPAA Privacy and Security Program to a Better

Place, Faster …

Earn up to 10.8 CPE Credits!

http://clearwatercompliance.com/bootcamps/

Designed for busy professionals, the Clearwater HIPAA and Cybersecurity BootCamp™ distills into one action-packed day, the critical information you need to know about the HIPAA Privacy and Security Final Rules and the HITECH Breach Notification Rule.

Join us for our next virtual, web-based events…Three, 3hr sessions:

• August 4th, 11th, 18th - 2016• November 3rd, 10th, 17th – 2016• February 9th, 16th, 23rd - 2017 • May 4th, 11th, 18th - 2017




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Other Upcoming Clearwater Events

Visit ClearwaterCompliance.com for more info!

July 21, 2016Complimentary

WebinarThe Critical

Difference: HIPAA Security Evaluation v HIPAA Security Risk

Analysis August 17, 2016 Complimentary

WebinarHow to Conduct a NIST-based Risk Assessment to Comply with

HIPAA & Other Regulations

July 28, 2016 Complimentary

WebinarHIPAA 101

August 3, 2016 Complimentary

WebinarHow to Adopt the NIST Cybersecurity

Framework

http://www.clearwatercompliance.com/

[email protected]

mailto:[email protected]

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