TM The HIPAA Privacy Rule: Safeguarding Health Information in Research and Public Health Practice Centers for Disease Control and Prevention Beverly A. Peeples, J.D. December 13, 2005

TM Brief Overview of HIPAA What is the Privacy Rule? Who is covered by the Privacy Rule? What information is protected?

TM What is the Privacy Rule? Establishes a set of national standards Promulgated by the US DHHS Addresses use and disclosure of individual’s health information Addresses standards and protection of individual’s privacy rights

TM Major Goals of Privacy Rule Assures that individual’s health information is properly protected Strives to maintain balance Designed to be flexible and comprehensive

TM Who is Covered by the Privacy Rule? Covered Healthcare Providers Known as Covered Entities (CE) Health Plans Healthcare Clearinghouses

TM What is a Covered Entity? Health Care Provider + Conducts electronic transactions

TM What is a HIPAA transaction? health care claims health care payment coordination of benefits health care claim status enrollment and disenrollment in a health plan

TM What is a HIPAA transaction? eligibility for a health plan health plan premium payments referral certification and authorization first report of injury health care claims attachments other transactions that the Secretary may prescribe by regulation.

TM Protected Health Information (PHI)  Individual’s past, present or future physical or mental health  Provision of healthcare  Past, present or future payment for provision of healthcare  Does not include FERPA records What Information is Protected?

TM Limits on Use of Individually Identifiable Health Information -Privacy Rule sets limits -Does not restrict ability of health care providers … to share information to treat patients -May not be used for purposes unrelated to health care

TM Limits on Use of Individually Identifiable Health Information Specific authorizations required before a CE can release information to a: −life insurer −bank −marketing firm or −school

TM Limits on Use of Individually Identifiable Health Information Permits health care providers and other CEs to share information about: −treatment options −disease-management programs When they have a treatment relationship with the individual

TM Limits on Use of Individually Identifiable Health Information A person or entity conducting certain functions on behalf of a CE --business associate CE may disclose PHI to a business associate CE must obtain satisfactory assurances to safeguard the information

TM Limits on Use of Individually Identifiable Health Information Privacy standards do not affect state laws Privacy Rule sets a national “floor” of privacy standards State law providing additional protections would continue to apply

TM What is the “Minimum Necessary” Standard? - CE must make reasonable efforts to disclose only the minimum amount of PHI - CEs may “reasonably” rely on public health authorities’ representation - Applies to disclosures to a public health agency

TM Exceptions to the “Minimum Necessary” Requirements  Minimum Necessary Standard does not apply if disclosures are:  Required by law  Authorized by individual  Requested by health care provider for treatment purposes

TM Exceptions to the “Minimum Necessary” Requirements Disclosures to the individual Disclosures to HHS When required for compliance with other HIPAA rules −e.g. to fill out required or situationally required data fields in standard transactions

TM Uses and Disclosures of PHI A covered entity may not use or disclose PHI except either −as the Privacy Rule permits or requires; or −as the individuals …or their …representatives authorize in writing

TM Permitted Uses and Disclosures without Authorizations To the individual For treatment, payment, and healthcare operations Opportunity to agree or object As incident Public interest and benefit activities Limited Data Set

TM Permitted Uses and Disclosures without Authorizations A limited data set is PHI from which certain specified direct identifiers or individuals and their relatives, household members, and employers have been removed. May contain more identifiers than deidentified data stripped of the 18 identifiers-still PHI

TM Written Authorizations Must be written in specific terms Must be in plain language Contain specific information

TM Written Authorizations Allows use and disclosure of PHI by the covered entity or a 3 rd party Examples of disclosures:  to a life insurer  to an employer  To a school employee who is not a heath care provider

TM Public Health Authority Public Health Authorities are not subject to the Privacy Rule −When they are conducting public health activities as defined in the Rule: −Even when they are covered entities acting in the capacity of a public health authority  Funded by a federal (CDC) or state public health authority  With a grant of authority to conduct a public health activity

TM Examples of PHAs Federal public health agencies Include: −CDC; NIH; SAMSHA; FDA; OSHA; and tribal health agencies State public health agencies include: −public health departments or divisions, state cancer registries; and vital statistics departments Local public health agencies include: −similar departments

TM Public Health Authorities Hybrid entities A hybrid entity is a single legal entity that is a CE, performs business activities that include both covered and noncovered functions, and designates its health care components as provided in the Privacy Rule.

TM Public Heath Authorities that are CE’s or Hybrid Entities A university or school that includes an academic medical center’s hospital is a CE It may choose to be a hybrid entity via designating the hospital as its health care component

TM Hybrid Entities A school clinic if it conducts electronic transactions −Bills for services −Files insurance reimbursement claims −Provides health care to students  Physical or mental health services

TM Highlights of the Privacy Rule - Contains standards to protect privacy of individuals identifiable health information - Sets minimum standards for how PHI may be used and disclosed; and - Individuals can have control of their health information

TM Highlights of the Privacy Rule −Describes methods to de-identify health information −Provides alternatives to obtaining an Authorization e.g. limited data sets −Important steps toward understanding:  how and why the Privacy Rule protects  How CEs implement the Rule’s standards

TM Contact Information Beverly A. Peeples, JD Privacy Rule Coordinator Office of Chief Science Officer Office of Scientific Regulatory Services Health Information Privacy Office PH: