In addition to introducing the concept of Meaningful use, the Health Information Technology for Economic and Clinical Health (HITECH) Act made significant changes to the Health Information Portability and Accountability Act (HIPAA) of 1996.
The biggest change to HIPAA compliance is the significant toughening of data breach notification laws, which now not only impose larger fines and require more extensive public notifications when data is lost, but also apply to a health care provider's business associates. Additional updates to HIPAA compliance affect the way providers are authorized to use personal health information for marketing and communication purposes.
The chart below summarizes the major changes made to the HIPAA Privacy and HIPAA Security rules by the HITECH Act. The Department of Health & Human Services outlined these changes in its proposed rule on HIPAA compliance modifications under the HITECH Act, although it should be noted that some of the modifications within that rule are independent of the HITECH Act.
Much of this information comes courtesy of the American Association of Oral and Maxillofacial Surgeons, whose research on HIPAA compliance was passed along by Christopher Paidhrin, security compliance officer for the Southwest Washington Medical Center in Vancouver.
|Definition of CE||Health plan, clearinghouse or provider involved in the disclosure of PHI||Expanded to include HIE, RHIO, e-prescribing gateway and subcontractor|
|Is a BA a CE?||No||Yes -- subject to HIPAA Privacy and HIPAA Security rules|
|Data breach notification||No direct obligation, though state laws vary||Notification required if more than 500 patients affected|
|Data breach enforcement||Collaborative investigation involving HHS and CE||HHS investigation to determine willful neglect1; expanded to include individual employees at CE and BA|
|Data breach penalties||Minimum of $100, maximum of $25,000||$100 to $50,000 per violation, with yearly maximum of $25,000 to $1.5 million and mandatory penalties for willful neglect|
|Sale of PHI||Allowed||Prohibited by CEs and BAs without valid authorization, save for certain conditions2|
|Use of PHI in marketing communications||Authorization required, with three exceptions -- CE services, treatment, case management/alternative treatment||Expanded to ban direct or indirect payment for communications; now applies to BAs|
|Dissemination of PHI to patients||Only if readily available||Must be provided, preferably in electronic format; fee cannot exceed labor cost|
|Fundraising opt-out||If patients opt out, CE must make "reasonable efforts" to stop||If patients opt out, CE must stop|
|Definition of electronic media||Limited to storage media, such as tape and disk||Expanded to reference Internet and VoIP technology|
Key to acronyms
BA = business associate
CE = covered entity
HHS = Department of Health & Human Services
HIE = health information exchange
PHI = personal health information
RHIO = regional health information organization
1The "conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated"
2Public health activities; research; treatment; services rendered by a BA; or "the sale, transfer, merger, or consolidation of all or part of a CE"
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