HIPAA Regulations

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What do you need to know?
DISCLAIMER
Please note that the information provided is to inform
our clients and friends of recent HIPAA and HITECH act
developments. It is not intended, nor should it be used,
as a substitute for specific legal advice
HIPAA Regulations
What do you need to know?
Rate your practice’s current compliance.
 Are you HIPAA Compliant right now?
 Privacy Rule compliance requirements
 Security Rule compliance requirements
 Breach notifications requirements
 Documentation
 Audits
Recent Breaches in the News
 Recent Breaches and their Costs!
 Experts: Lack of HIPAA basics cost BCBST $18.5 million
 Basic compliance 101—policies, training, monitoring, and risk
assessments—may have saved Blue Cross Blue Shield of Tennessee
(BCBST) millions, experts say.
 Instead, the health insurer agreed to a $1.5 million settlement with
the Office for Civil Rights (OCR) over potential HIPAA security
violations and spent another $17 million in breach response costs.
 In the fall of 2009, BCBST reported to OCR that 57 unencrypted
computer hard drives were stolen from a leased facility in
Tennessee. The hard drives contained protected health information
(PHI) for more than one million individuals, including member
names, Social Security numbers, diagnosis codes, birthdates, and
health plan identification numbers.
WHY SHOULD I CARE?
OCR's investigation of Phoenix Cardiac Surgery PC (2 physician practice)
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/pcsurgery
_agreement.pdf
 failed to implement adequate policies and procedures to appropriately
safeguard patient information;
 failed to document that it trained any employees on its policies and
procedures on the Privacy and Security Rules;
 failed to identify a security official and conduct a risk analysis
 failed to obtain business associate agreements with Internet-based
email and calendar services where the provision of the service included
storage of and access to its ePHI.
 Corrective Action Plan required
 Penalty - $100,000
 Reputation Impact?
OCR Findings from 2005-2010
Does your practice have a Designated HIPAA Privacy
Officer?
 Failure to demonstrate adequate policies and
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procedures or safeguards to address response and
reporting of security incidents
Security awareness and training
Access controls
Information access management
Work station security
HIPAA Privacy Rule
45 CFR Part 160 and Part 164, Subparts A and E.
 Designate a HIPAA Privacy Officer
 Update your Notice of Privacy Practices
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html
 New additional patient rights related to Privacy of their
information and their access to it.
 Conduct Compliance Audits
 Conduct Annual Training of Staff on Privacy Rule
policies and procedures
 Document all disclosures according to the Privacy Rule.
HIPAA Security Rule
45 CFR Part 160 and Part 164, Subparts A and E.
 Accountability, Penalty, and Persecution for disclosure
of/access to ePHI
 Protecting ePHI at rest, in transit, and in destruction.
 Breach Reporting
 Auditing
 3 sets of Safeguards (standards)
 Administrative
 Physical
 Technical
BREACH NOTIFICATION RULE
HITECH ACT SECTION 13402
 Definition of a “Breach”.
A breach is, generally, an impermissible use or disclosure under the
Privacy Rule that compromises the security or privacy of the protected
health information such that the use or disclosure poses a significant risk
of financial, reputational, or other harm to the affected individual.
 Requirements
Following a breach of unsecured protected health information covered
entities must provide notification of the breach to affected individuals,
the Secretary of HHS and, in certain circumstances, to the media. In
addition, Business Associates must now notify covered entities of a
breach if it occurred due to their actions or processes.
BREACH NOTIFICATION RULE
 Individual Notice - within 60 days of breach
 First class mail
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Include description of the breach, description of the data
involved, Protective steps for individuals, an action plan to
resolve, mitigate and prevent further breaches.
 For unknown or out of date information on affected
individuals. Notification should be done via an
announcement on Covered Entities Website or in local
media where the affected individual resides.
 Media Notice - within 60 days of breach
 For Breaches of more than 500 patients
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Include description of the breach, description of the data
involved, Protective actions for individuals, Action plan to
resolve, mitigate and prevent further breaches.
BREACH NOTIFICATION RULE
 Notice to Secretary of Health and Human Services
 For breaches of less than 500 individuals
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File a report on HHS website annually
 For breaches of more than 500 individuals
 File a report on the HHS website within 60 of the breach.
 Notification by Business Associates
 Business Associates required to notify the Covered Entity
upon discovery of any breach within 60 days
 Business associate should provide the covered entity with the
identification of each individual affected by the breach as well
as any information required to be provided by the covered
entity in its notification to affected individuals
Documentation
 HIPAA Privacy Rule Policies and Procedures
 Accounting of disclosures
 Notice of Privacy Practices
 Record of periodic workforce training
 HIPAA Security Rule Policies and Procedures
 Documentation of periodic risk assessments
 Record of Security Audits
 Record of periodic workforce training
Auditing
 Need to have written policies and procedures stating
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how often and what you will be monitoring, reviewing
Audit Logs
Access Reports
Security incident tracking reports.
Documentation of user access roles and
granting/revocation of access upon termination or
change in user role.
HIPAA Audits Protocol
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/au
dit/protocol.html
 78 Privacy Rule Audit protocols
 77 Security Rule Audit protocols
 10 Breach Notification Rule Audit protocols
A Few Last Thoughts
 Form a TEAM at your practice, Include one member
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from each area, Providers, Nursing, Billing, front desk
Perform a Risk Assessment to identify how ePHI is
created, used, transmitted, and disposed of.
Designated a HIPAA Privacy and Security Officer
Create and Maintain Updated policies and procedures
Develop and document your practice’s Breach
Notification procedures
Periodically monitor your systems (Audit)
Consider Email encryption if you need to email ePHI
Resources
 HIPAA Privacy Rule
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http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/ind
ex.html
HIPAA Security Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/in
dex.html
HIPAA Breach Notification Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificati
onrule/index.html
HIPAA Audit Protocols
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/protocol.ht
ml
HIPAA Consultants (education, training, consulting)
 HCPRO Blogs -http://blogs.hcpro.com/hipaa/
 ecFirst - http://www.ecfirst.com/
 Clearwater Compliance - http://clearwatercompliance.com/
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