ISO/TS 17975:2015 en

Health informatics - Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information

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Status Definitief
Aantal pagina's 34
Gepubliceerd op 15-09-2015
Taal Engels
ISO/TS 17975 defines the set of frameworks of consent for the Collection, Use and/or Disclosure of personal information by health care practitioners or organizations that are frequently used to obtain agreement to process the personal health information of subjects of care. This is in order to provide an Informational Consent framework which can be specified and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdictions, countries) as an aid to the consistent management of information in the delivery of health care services and the communication of electronic health records across organizational and jurisdictional boundaries. The scope of application of this Technical Specification is limited to Personal Health Information (PHI) as defined in ISO 27799, “information about an identifiable person that relates to the physical or mental health of the individual, or to provision of health services to the individual. This information might include: - information about the registration of the individual for the provision of health services; - information about payments or eligibility for health care in respect to the individual; - a number, symbol or particular code assigned to an individual to uniquely identify the individual for health purposes; - any information about the individual that is collected in the course of the provision of health services to the individual; - information derived from the testing or examination of a body part or bodily substance; - identification of a person, e.g. a health professional, as a provider of healthcare to the individual.” Good practice requirements are specified for each framework of Informational Consent. Adherence to these requirements is intended to ensure any subject of care and any parties that process personal health information that their agreement to do so has been properly obtained and correctly specified. The Technical Specification is intended to be used to inform: - discussion of national or jurisdictional Informational Consent policies; - ways in which individuals and the public are informed about how personal health information is processed within organizations providing health services and health systems; - how to judge the adequacy of the information provided when seeking Informational Consent; - design of both paper and electronic Informational Consent declaration forms; - design of those portions of electronic privacy policy services and security services that regulate access to personal health data; - working practices of organizations and personnel who obtain or comply with consent for processing personal health information. The Technical Specification does not: - address the granting of consent to the delivery of healthcare-related treatment and care. Consent to the delivery of care or treatment has its own specific requirements, and is distinct from Informational Consent. Note that as Consent to Treatment and Care are outside the scope of this Technical Specification, the phrase “informational consent” is hereafter supplanted by the shorter “consent”. In every case, it is Informational Consent that is intended; - specify any jurisdiction’s legal requirements or regulations relating to consent. The focus is on frameworks, not on jurisdictional legislation or its adequacy in any given jurisdiction. While care has been taken to design the frameworks so that they do not conflict with the legislation in most jurisdictions, they might challenge some existing practices. This Technical Specification uses an approach that allows organizations or jurisdictions to select a subset of those frameworks which best fit their law culture and approach to data sharing; - specify what consent framework is to be applied to a data classification or data purpose as this may vary according to law or policy, although some examples of implementation profiles are provided in an informative Annex; - determine the legal adequacy of the information up


ICS-code 35.240.80
Nederlandse titel Health informatics - Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information
Engelse titel Health informatics - Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information



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