What is HIPAA?
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. HIPAA covers the following entities:
- Health plans
- Health care providers
- Health care clearinghouses
- Employers that store, manage, or communicate protected health information (PHI)
What is PHI?
Health Information Health information means any information, whether oral or recorded in any form or medium, that:
- Is created or received by an HIPAA covered entity: health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
- Relates to 1) the past, present, or future physical or mental health or condition of any individual, 2) the provision of health care to an individual, or 3) the past, present, or future payment for the provision of health care to an individual.
Individually Identifiable Health Information Individually identifiable health information is information that is a subset of health information, including demographic information collected from an individual, and:
- Is created or received by an HIPAA covered entity: health care provider, health plan, employer, or health care clearinghouse; and
- Relates to 1) the past, present, or future physical or mental health or condition of an individual; 2) the provision of health care to an individual; or 3) the past, present, or future payment for the provision of health care to an individual; and
- That identifies the individual; or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
Protected Health Information (PHI) Protected health information (PHI) means individually identifiable health information:
- Transmitted by electronic media;
- Maintained in electronic media; or
- Transmitted or maintained in any other form or medium.
The Safe Harbor Provision According to the Safe Harbor provision of HIPAA, the following information should be regarded as “Protected Health Information” unless demonstrated otherwise through statistical analysis:
- Social Security numbers
- Telephone numbers
- All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combing all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000
- All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
- Fax numbers
- Electronic mail addresses
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- Biometric identifiers, including finger and voice prints
- Full face photographic images and any comparable images and
- Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the research data)
The Privacy Rule requires that the Covered Entity may only release PHI with the prior written consent of the individual who is the subject of the records. The Privacy Rule also contains a number of notification requirements and administrative requirements designed to ensure proper records are maintained and that individuals are aware of their rights under HIPAA.
The HIPAA Privacy Rule covers protected health information in any medium.
The Security Rule requires the implementation of “reasonable and appropriate” measures to protect the confidentiality, integrity and availability of ePHI for all information systems that process ePHI within the Covered Entity. These specifications fall into five categories:
- Administrative Safeguards
- Physical Safeguards
- Technical Safeguards
- Organizational Requirements
- Policies and Procedures
The key to compliance with the Security Rule lies in the language of the law: implementing “reasonable and appropriate” measures.
The HIPAA Security Rule covers electronic protected health information (ePHI).
If you want to use PHI for research and development work, like for software testing purposes when you are developing an eHealth application, you need to de-identify the PHI information first. According to HIPAA, there are three ways to “de-identify” health information:
- Safe Harbor: You can completely remove the 18 types of PHI specified in the HIPAA Safe Harbor provision. This wholesale removal is sufficient provided it is reasonably unlikely someone will use the remaining information (alone or in combination with other data) to identify an individual patient.
- Statistical Expertise: You can rely on the statistical expertise of yourself or a third party to determine the risk associated with a particular type of PHI and exclude it only if necessary. This applies to the 18 types of PHI specified in HIPAA Safe Harbor provision and to any other information.
- Encryption: You can encrypt the PHI to create an acceptably low probability that the information is likely to be re-identified.
For more information of HIPAA, please refer to the following links: