title: Impact of the privacy rule on the study of out-of-hospital pediatric cardiac arrest.
abstract: BACKGROUND
  The Privacy Rule, a follow-up to the Health Insurance Portability and Accountability Act, limits distribution of protected health information. Compliance with the Privacy Rule is particularly challenging for prehospital research, because investigators often seek data from multiple emergency medical services (EMS) and receiving hospitals.
  
  
  OBJECTIVE
  To describe the impact of the Privacy Rule on prehospital research and to present strategies to optimize data collection in compliance with the Privacy Rule. Methods. The CanAm Pediatric Cardiopulmonary Arrest Study Group has previously conducted a multicentered observational study involving children with out-of-hospital cardiac arrest. In the current study, we used a survey to assess site-specific methods of compliance with the Privacy Rule and the extent to which such strategies were successful.
  
  
  RESULTS
  The previously conducted observational study included collection of data from a total of 66 EMS agencies (range of 1-37 per site). Data collection from EMS providers was complicated by the lack of a systematic approval mechanism for the research use of EMS records and by incomplete resuscitation records. Agencies approached for approval to release EMS data for study purposes included Department of Health Institutional Review Boards, Fire Commissioners, and Commissioners of Health. The observational study included collection of data from a total of 164 receiving hospitals (range of 1-63 per site). Data collection from receiving hospitals was complicated by the varying requirements of receiving hospitals for the release of patient survival data.
  
  
  CONCLUSIONS
  Obtaining complete EMS and hospital data is challenging but is vital to the conduct of prehospital research. Obtaining approval from city or state level IRBs or Privacy Boards may help optimize data collection. Uniformity of methods to adhere to regulatory requirements would ease the conduct of prehospital research.
authors.affiliation: Department of Pediatrics, Division of Pediatric Critical Care, The Children's Hospital of New York-Presbyterian, Columbia University, New York, New York 10032, USA. Mcm2113@columbia.edu
authors.forename: Marilyn C
authors.initials: MC
authors.lastname: Morris
authors.forename: C Crawford
authors.initials: CC
authors.lastname: Mechem
authors.forename: Robert A
authors.initials: RA
authors.lastname: Berg
authors.forename: Bentley J
authors.initials: BJ
authors.lastname: Bobrow
authors.forename: Starla
authors.initials: S
authors.lastname: Burns
authors.forename: Lani
authors.initials: L
authors.lastname: Clark
authors.forename: Valerie J
authors.initials: VJ
authors.lastname: De Maio
authors.forename: Monique
authors.initials: M
authors.lastname: Kusick
authors.forename: Neal J
authors.initials: NJ
authors.lastname: Richmond
authors.forename: Ian
authors.initials: I
authors.lastname: Stiell
authors.forename: Vinay M
authors.initials: VM
authors.lastname: Nadkarni
mesh_terms: D004632:Emergency Medical Services; D019538:Health Care Surveys; D020408:Health Insurance Portability and Accountability Act; D006323:Heart Arrest; D006801:Humans; D010372:Pediatrics; D018907:Privacy / Q000331:legislation & jurisprudence*; D014481:United States