II. Definition: Security Rules
- HIPAA Security Rule Proposed (1998)
- HIPAA security rules must be adhered to when transmitting medical data over telecommunications networks
- Ensure confidentiality, integrity and availability of all protected health information (e-PHI)
- Identify and protect against reasonably anticipated threats to security or integrity of information
- Protect against reasonably anticipated impermissable uses or disclosures
- Ensure workforce compliance (typically in conjunction with the organization's general counsel)
- HIPAA Security - Final Rule (2003)
- Specifically sets standards for administrative, physical and technical safeguards
III. Definition: Privacy Rules
- HIPAA Privacy Rule
- Federal protections related to individually identifiable patient health information
- Allows for disclosure of health information when needed for patient care and related important uses
- Medical providers may discuss patient with other providers caring for patient (consultants, pharmacists...)
- Immunization information may be released with verbal consent by patient or parent
- Healthcare providers are not covered by HIPAA if they do NOT transmit health information electronically
- HIPAA Limited Data Set
- Clinical data set that conforms to HIPAA definition may be shared with another institution that agrees to the same guidelines
- May contain dates of diagnosis, even sensitive diagnoses such as HIV Test results
- Defined in 45 CFR 164.514(e) of the HIPAA Privacy Rule
- Must exclude identifying information (about the patient, family members, housemates, employers)
- Names
- Address (except for town, city, state, zip code)
- Phone or fax numbers
- Social security numbers, medical record numbers or health plan beneficiary numbers
- Account numbers or license/certificate numbers
- Vehicle identifiers, serial numbers or license plate numbers
- Web URLs or IP Addresses
- Biometrics (e.g. finger or voice prints)
- Photographs identifying the patient (e.g. face)
IV. History
- 1995-1996
- HIPAA Privacy Act first passed in U.S. (Kennedy-Kassebaum Bill)
- Key legislation focus was initially insurance regulation (e.g. reduced denial based on pre-existing conditions, portability across jobs)
- 2009 American Recovery and Reinvestment Act (ARRA) related changes to HIPAA
- Addressed additional data restrictions, disclosures (e.g. security breaches), protected health information sales and reporting requirements
- Business associates are held to same HIPAA standards as health organizations
- Update Business Associate Agreements (BAA) to document policies and procedures to protect patient data
- In case of data security breach, business associates must notify the affected entities and Health and Human Services
- 2013 HIPAA Final Rule
- Patient information on mobile devices must be secured with a strong password
- Patient data and messages must be encrypted
- Patients may restrict insurers from being notified of their cash purchases
- Patients may request electronic copies of their records
- Electronic claim transactions must be standardized
V. Legal: Disclosure rules
- Patient alert with intact Decision-Making Capacity
- Patient has right to agree or to object to release of information to others
- There is no "implied" authorization of public health information under HIPAA
- Patient Visitors
- Protected information does not apply (no restriction on disclosure about the visitor)
- Dangerous patient
- Serious, imminent health and safety threat to an individual or to the public
- Suicidality or other serious mental illness interfering with Decision-Making Capacity
- Emergency in which person unable to provide consent
- Disclosure may be performed in best interest of patient
- Informal consent to family or friends as to relate care or payment for care
- Notification of patient location, status or death to family or others responsible for patient's care
- Entities related to active disaster relief
- Attorney
- Requires signed release of information by patient
- Law enforcement
- Requires signed release of information by patient or power of attorney or a court order (or similar authorization)
- Release may be warranted where directly applicable to criminal investigation (discuss with organization attorneys)
- Required by law such as court order, warrant, subpoena
- Location of suspect, fugitive, witness or missing person
- Victim of a crime (or suspected victim)
- Patient death if that death is suspected to be related to a crime
- Health information is thought to be evidence of a crime that occurred on health facility premises
- Medical emergency related to a crime
- Press
- Requires signed release of information by patient
- Public Health Department or other similar federal agency protecting public health and safety
- Information to prevent or control disease, injury or Disability (e.g. Sexually Transmitted Disease)
- Child Abuse or neglect
- Seizure Disorder, Epilepsy, hypoglycemic episode or other event resulting in Impaired Driving risk
- FDA
- Adverse event reporting
- Product tracking, recalls and surveillance
- Individuals
- May be notified of exposure to communicable disease
- Employers
- Work-Related Illness or injury as it applies to workplace health and safety
- Health care facility
- Health information as it relates to treatment, payment and operations related activity
- Health information as it relates to provider or other facility quality, competency, fraud, abuse, compliance regarding a specific mutual patient
VI. Precautions: Secure Patient Communication
- HIPAA Security rule requires that covered entities perform a risk analysis to decide which forms of Patient Communication are acceptable
- Secure messaging via a patient portal or encrypted email may be preferred
- Unencrypted email is not excluded, but additional precautions should be taken, and patient's may refuse this mode of communication
- Text messaging is not defined by the current HIPAA regulations as of 2014, but may be at increased risk of interception
- Direct Project is working on standards to securely send health information directly to recipients
VII. Resources
- Summary of the HIPAA Privacy Rule (2003)
VIII. References
- (2013) Presc Lett 20(8): 48