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 Design

• Registries shall be developed with clear and precisely defined purpose to avoid both ethical and compliance issues that may undermine the achievement of the registry's objectives.
  
• A governance structure for registries shall be formalized to ensure accountability, oversee resource application, provide focus and optimize output from registries. All personnel involved in the use of registries must be familiar and abide with administrative and legislative requirements.
  
• Methods involved in the registry such as but not limited to data collection, data reporting, and addressing of outliers shall be documented.
  
• A security assessment approach shall be employed to identify measures to be taken to address any identified security gaps.
  

Informed Consent

• 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.
  

Registry Data

• Data elements shall conform to standard definitions, terminologies and specifications. It must be used to enable meaningful comparisons and allow maximum benefit to be gained from linkage to other registries and/or databases.
  
• Data dictionaries shall be established to ensure that a systematic identical approach is taken during data collection and data entry. Registry reports shall be produced according to a strict timeline.
  
• For data previously collected, the privacy conditions under which they were collected shall be set as the minimum privacy conditions.
  
• Audit of registry data shall be done frequently to promptly identify data quality lapses.
  

Data Collection

• Data collection shall be done in a systematic approach, with identical approaches used at different institutions ensuring that it shall not be an unreasonable burden to patients, nor incur any cost.
  
• Collection of data shall be done as close as possible to the time and place of care by appropriately trained data collectors. Registry participants or their next of kin shall be made aware of the collection of data.
  

Registry data for Research Purposes

• 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 Review Board, Ethics Review Board or Privacy Board.
  

Registries for Vulnerable Population

• Registries compiling health information from vulnerable population such as but not limited to pregnant women, human fetuses, neonates, prisoners, children, and patients having rare diseases shall employ special efforts to protect identities of these subjects.
  

Linking of Registries

• 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.
  
• The terms register and registry are often used interchangeably. The registry is the organization and process that supports a register and should be distinguished from the register itself. A registry may support a number of individual registers.
  

• "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.
• Newton,J., Garner,S., Disease Registers in England. (Feb 2002). Institute of Health Sciences,

• Australian Commission on Safety and Quality in Health Care, Framework for Australian clinical quality registries.Sydney. ACSQHC, March 2014.
  

• Privacy Set of Rules (SOR)