Personal Health Information - Privacy and Security principles

Outgoing HHS Secretary Mike Leavitt articulated his own "doctrine" on privacy and security of patient medical data. He is attempting to tackle two conflicting forces - accessibility vs. protection against unintended use. I like the strong emphasis on personal control - patient is in charge of who can access their data and how. I would like to see made explicit the notion that clinical content should really be authored by medical professionals and this authorship be clearly separated from content provided by the patient or other stakeholders. While privacy and security are clearly distinct from the realm of interoperability, I am concerned that principles below seem to regard patient data as being meant solely for human consumption - it's worthwhile keeping in mind that making this data machine-processable and truly interoperable holds enormous promise of higher quality, more cost efficient and - most importantly - correct, timely and safer care. Here are Mike Leavitt's eight principles:

Individual Access – Consumers should be provided with a simple and timely means to access and obtain their personal health information in a readable form and format.

Correction – Consumers should be provided with a timely means to dispute the accuracy or integrity of their personal identifiable health information, and to have erroneous information corrected or to have a dispute documented if their requests are denied. Consumers also should be able to add to and amend personal health information in products controlled by them such as personal health records (PHRs).

Openness and Transparency -- Consumers should have information about the policies and practices related to the collection, use and disclosure of their personal information. This can be accomplished through an easy-to-read, standard notice about how their personal health information is protected. This notice should indicate with whom their information can or cannot be shared, under what conditions and how they can exercise choice over such collections, uses and disclosures. In addition, consumers should have reasonable opportunities to review who has accessed their personal identifiable health information and to whom it has been disclosed.

Individual Choice -- Consumers should be empowered to make decisions about with whom, when, and how their personal health information is shared (or not shared).

Collection, Use, and Disclosure Limitation – It is important to limit the collection, use and disclosure of personal health information to the extent necessary to accomplish a specified purpose. The ability to collect and analyze health care data as part of a public good serves the American people and it should be encouraged. But every precaution must be taken to ensure that this personal health information is secured, deidentified when appropriate, limited in scope and protected wherever possible.

Data Integrity – Those who hold records must take reasonable steps to ensure that information is accurate and up-to-date and has not been altered or destroyed in an unauthorized manner. This principle is tightly linked to the correction principle. A process must exist in which, if consumers perceive a part of their record is inaccurate, they can notify their provider. Of course the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule provides consumers that right, but this principle should be applied even where the information is not covered by the Rule.

Safeguards – Personal identifiable health information should be protected with reasonable administrative, technical, and physical safeguards to ensure its confidentiality, integrity, and availability and to prevent unauthorized or inappropriate access, use, or disclosure.

Accountability – Compliance with these principles is strongly encouraged so that Americans can realize the benefit of electronic health information exchange. Those who break rules and put consumers’ personal health information at risk must not be tolerated. Consumers need to be confident that violators will be held accountable.