1. HIPAA
Privacy And Security
Presented by:
Michele Madison
Partner, Healthcare &
Healthcare IT Practices
Morris, Manning & Martin, LLP
mmadison@mmmlaw.com
Direct: 404-504-7621

2. Privacy and Security
2

3. HIPAA Omnibus Rule Purpose
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Final Rule Addresses 4 Proposed Rules
Published in 2009 and 2010
1. Strengthen the HIPAA Privacy and Security Requirements
Mandated by HITECH (Proposed Rule July 2010)
• Strengthen Restrictions on Marketing and Fundraising Activities
• Enhanced Patient Rights on Access and Restricting Disclosures to
Health Plans
• Modify the Notice of Privacy Practices
• Modify the Authorization process
• Expands Direct Enforcement of HIPAA Requirements and Penalties
to Business Associates

4. HIPAA Omnibus Rule Purposes
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2. Adopt changes to the Enforcement Rule (Proposed
October 2009)
• New Tiered Civil Monetary Penalties Standards
• Increased Monetary Penalties
3. Modifies the Breach Notification for Unsecured Protected
Health Information by replacing the breach notification
rule‘s ‗‗harm‘‘ threshold with a more objective standard.
(Proposed Rule August 2009 –supplanted)
4. Modifies HIPAA to conform with Genetic Information
Nondiscrimination Act

5. Important Dates and Laws
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1. HIPAA – Privacy Rule Effective on April 14, 2003
Security Rule Effective on April 20, 2005
2. HITECH signed February 17, 2009
• Interim Final Rule on Breach of Unsecured PHI– August 24, 2009
and effective on September 23, 2009
• Interim Final Rule on Civil Monetary Penalty—October 30, 2009
and effective on November 30, 2009
• Proposed Rule on July 14, 2010
3. GINA 2008 – Proposed Rule to address HIPAA on
October 7, 2009

6. Effective Dates
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Final Rule Provisions:
 Final Rule Effective on March 26, 2013
 Compliance Deadline September 23, 2013 (for
Privacy and Security)
 Business Associates flexible compliance date
standards
 Transition provisions permit time to address
documents and practices to establish compliance

7. Security Risk Assessment
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 Ensure the full Risk Assessment has been completed
- Administrative
- Physical
- Technical Safeguards
 This is part of the Meaningful Use Requirements

8. Security Breach Notification
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• Old standard: Notification required where ―significant risk of financial,
reputational, or other harm to individual‖. Burden was on CE or BA
to show there was no significant risk.
• New standard: Subject to certain existing exceptions, any access,
use or disclosure of unsecured PHI in violation of Privacy Rule is
presumed a breach unless demonstrate low probability that PHI has
been compromised based on risk assessment involving at least the
following factors:
– Nature and extent of PHI involved, including types of identifiers and likelihood of
re-identification
– Unauthorized person who used the PHI or to whom disclosure was made
– Whether PHI was actually acquired or viewed
– Extent to which risk to PHI has been mitigated
• Rule also eliminates exception for limited data sets that do not
contain dates of birth or zip codes.

9. Common Violations
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 Of the 90,000 complaints investigated most are, compiled
cumulatively, in order of frequency:
 Impermissible uses and disclosures of protected health
information;
 Lack of safeguards of protected health information;
 Lack of patient access to their protected health information;
 Uses or disclosures of more than the minimum necessary
protected health information; and
 Lack of administrative safeguards of electronic protected
health information.

10. Most Common Violators
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The most common types of covered entities that have been
required to take corrective action to achieve voluntary
compliance are, in order of frequency:
 PRIVATE PRACTICES;
 General Hospitals;
 Outpatient Facilities;
 Health Plans (group health plans and health insurance
issuers); and,
 Pharmacies.

11. Enforcement Activities
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Adult & Pediatric Dermatology, P.C., of Concord,
Massachusetts (APDerm) -$150,000.00
Affinity Health Plan, Inc. will settle potential violations of the
Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy and Security Rules for $1,215,780.
WellPoint Inc. has agreed to pay the U.S. Department of
Health and Human Services $1.7 million to settle potential
violations of the Health Insurance Portability and Accountability
Act of 1996 (HIPAA) Privacy and Security Rules

12. Major Steps to Take Now
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• Evaluate BA and subcontractor status
• Evaluate BA and subcontractor agreements for compliance and
amend as appropriate
• Evaluate whether BAs and subcontractors are federal common law
agents
• Review Security Rule compliance
• Implement BA policies and procedures as appropriate—for example,
minimum necessary
• Amend security breach policies and procedures appropriately
• Ensure the Security Risk Assessment and policies are completed
and in effect

13. Questions
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Michele Madison, Partner, Morris, Manning & Martin, LLP
Healthcare & Healthcare IT Practices
mmadison@mmmlaw.com
Direct: 404-504-7621