Privacy Wiki

Patient Registry- refers to the organisation and processes supporting a patient register– a set of patient records systematized around a particular disease, condition or exposure, and serving “one or more predetermined scientific, clinical or policy purposes” (AHRQ,2007)

• Registry developers shall prospectively apply careful scrutiny to the proposed purposes for and activities of a registry to avoid both ethical and compliance issues that may undermine achievement of the registry's objectives.
  
• In all circumstances, the consent process should ensure that clear notice is given to patients about the extent of privacy protections they may expect from their health information when it is incorporated into a registry.
  
• Health information registries for research shall incorporate an appropriate design and data elements, written operating procedures, and documented methodologies, as necessary, to ensure the fulfillment of a valid scientific purpose.

  • Where an authorization for the use and disclosure of registry data for future research does not exist, health care provider or health insurance plan maintaining the registry shall need to obtain an additional authorization for the research from individuals or seek a waiver of authorization from an Institutional Research Board or Privacy Board.
    
  • When using previously collected data, set as minimum the privacy conditions under which the data were collected initially.
  • If a dataset is going to be linked to another, an independent review of privacy risks (example: reidentification, fraud) involved must be conducted.

  
  

Notes:

• The objectives of any registry are to enhance the value of the health care services received, not to undermine the credibility and thus effectiveness of health care providers and insurance plans in their communities.
  

• "Legal and Ethical Considerations for Registries" In: Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr.

• Privacy Set of Rules (SOR)