HIPAA Update. Bob Radecki W.J. Flynn and Associates, LLC

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1 HIPAA Update Bob Radecki W.J. Flynn and Associates, LLC

2 Background ARRA American Recovery and Reinvestment Act of 2009 HITECH Health Information Technology for Economic and Clinical Act (Title XII, Part D of ARRA) $ s for EHRs Amendments to HIPAA Privacy and Security Requirements

3 HIPAA Changes in ARRA/HITECH Changes to Enforcement Series of Changes to Existing Rules New Compliance Obligations for Business Associates HIPAA Breach Notification Rules

4 Enforcement HITECH makes a number of changes to increase the enforcement of HIPAA Privacy and Security Rules HHS required to conduct periodic audits Penalties collected with be used to finance additional HHS enforcement Beginning on 2012 a % of penalty collected will be paid to harmed individuals Significant increase in potential penalties State Attorneys General have option to pursue prosecution of HIPAA violations

5 ARRA Changes to HIPAA

6 Right to Restrict Disclosures Current HIPAA Rule Individuals may request certain restrictions on use and disclosure of PHI however CE not required to comply with request New Rule Effective 2/17/2010 Provider required to comply with a request to restrict disclosure of PHI to a Health Plan for a service the individual paid for out-of-pocket

7 Accounting of Disclosures Current HIPAA Rule Accounting of certain disclosures must be provided but Disclosures for Treatment, Payment and Health Care Operations (TPO) are exempt New Rule for CE using EHR Provide accounting of ALL disclosures in previous 3 years, contained in EHR - including TPO. EHR vendors will be working to develop this capability Compliance Deadline EHR adopted by 1/1/09 Comply by 1/1/2014 EHR adopted on or after 1/1/09 Comply by 1/1/2011 or when EHR adopted whichever is later

8 Patient Access to PHI Current HIPAA Rule Patients have a right to access and obtain a copy of their records. CE can charge fee for producing (printing cost, etc) New Rule for CE using EHR Effective 2/17/2010 Must provide electronic copy of patient records Must agree to transmit information to a third party specified by individual (e.g. third party personal health record) Cannot charge a fee that exceeds cost of labor

9 Restrictions on Marketing Current HIPAA Rule Must get individuals prior written authorization prior to Marketing Exceptions to authorization requirement - communications for treatment of the patient, case management, care coordination, or to direct to alt. treatments or providers New Rule Effective 2/17/2010 If CE receives remuneration, must have a prior written authorization Exceptions Communications that describe Rx currently being prescribed for individual Compensation paid to BA performing legitimate BA service

10 Other Changes Awaiting Regulations Minimum Necessary Rule Current HIPAA Rule CE required to use and/or disclose only the minimum necessary amount of PHI for the purpose New Rules Effective upon Issuance of Guidance by HHS Sale of PHI Direct or indirect receipt of remuneration in exchange for PHI prohibited without individuals written authorization Regulations due August 17th, Effective date, 6 months after regulations released (Feb. 2011?)

11 Breach Notification Rules

12 Breach Notification HITECH Breach Notification Requirements Must notify individuals Must submit breaches annually to HHS If breach involves more than 500 individuals CE must HHS and possibly the media HHS will post these breaches on HHS website Breach Notification Regulations Published August 24th, 2009 See Handout for additional details Compliance Deadline September 23th, 2009!

13 Breach Notification Definition of Breach the acquisition, access, use, or disclosure of PHI in a manner Not permitted under HIPAA Which compromises the security or privacy of the PHI Must constitute a violation of the Privacy Rule Must pose a significant risk of financial, reputational, or other harm to the individual

14 Breach Notification Risk assessment to determine if significant risk of harm Who impermissibly used or to whom the information was impermissibly disclosed Circumstances where a covered entity takes steps to mitigate harm Circumstances where impermissibly disclosed PHI is returned Consider the type and amount of PHI involved in the impermissible use or disclosure.

15 Breach Notification Exceptions to Breach CE not responsible for a breach by a third party to whom it permissibly disclosed PHI Violations that are exceptions to the definition of breach Internal - violations involving individuals contained within CE/BA When an unauthorized person would not reasonably have been able to retain information

16 Breach Notification Determining if a Breach Has Occurred First, the CE must determine whether there has been an impermissible use or disclosure of PHI under the Privacy Rule Second, CE must determine, and document, whether the impermissible use or disclosure compromises the security or privacy of the protected health information Lastly, determine whether the incident falls under one of exceptions to breach definition

17 Breach Notification Unsecured PHI Notice required if PHI is not secured through a technology or methodology specified by HHS Specified encryption and destruction as the approved methods for rendering PHI unusable If encrypted or destroyed, breach notification not required Guidance on securing PHI issued April 17, notificationrule/brguidance.html

18 Breach Notification Notification to Individuals Following the discovery of a breach CE will notify each individual without unreasonable delay In no case later than 60 calendar days Breach shall be treated as discovered as of the first day the breach is known to the CE CE deemed to have knowledge of breach when any person (other than person committing the breach) who is a workforce member or agent of CE knows Ensure workforce members are adequately trained and aware of the importance of timely reporting

19 Breach Notification Notification must include: A brief description of what happened, Inc. date of the breach and date of the discovery Description of types of PHI involved Steps individuals should take to protect themselves from potential harm Description of what CE is doing to investigate, mitigate harm & protect against breaches Contact info including toll-free phone number, e- mail address, web site, or postal address

20 Breach Notification Provide notice to the individual in written form by first-class mail at the last known address notice only if individual has agreed in advance to receive electronic notice Substitute Notice, when CE does not have contact information Fewer than 10 individuals On-site poster, by telephone, or other means 10 or more individuals Conspicuous posting for 90 days on home page of web site Or conspicuous notice in major print or broadcast media

21 Breach Notification Notification to the Media Notice must be provided to media following a breach of more than 500 residents of a State Must include same information as notification to individual Notification to the HHS 500+ individuals CE to notify HHS immediately Less than 500 individuals Maintain records and annually submit on HHS website

22 Breach Notification Law Enforcement Delay If law enforcement official determines that a notification would impede a criminal investigation Administrative Requirements CEs must document policies and procedures Train workforce members Sanctions for employee failure to comply with policies Permit individuals to file complaints and refrain from intimidating or retaliatory acts

23 Resources HHS Breach Notification Page e/breachnotificationrule/index.html MMIC Risk Management Department W.J. Flynn and Associates, LLC HIPAA Consulting and Tools /tools.html

24 Questions Bob Radecki W.J. Flynn and Associates, LLC

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