BSI PD ISO/TS 17975:2022 – TC:2023 Edition

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Tracked Changes. Health informatics. Principles and data requirements for consent in the collection, use or disclosure of personal health information

Published By	Publication Date	Number of Pages
BSI	2023	102

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Categories: 35.240.80 - IT applications in health care technology, BSI

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PDF Catalog

PDF Pages	PDF Title
1	30466325
59	A-30442718
60	National foreword
64	Foreword
65	Introduction
69	1 Scope
70	2 Normative references 3 Terms and definitions
74	4 Abbreviated terms 5 Consent requirements 5.1 General
75	5.2 Informational consent 5.3 Consent to treatment versus informational consent 5.4 How consent relates to privacy, duty of confidence and to authorization
76	5.5 Relationship of consent to OECD guidelines 5.6 Relationship of consent to legislation 5.7 Expectations and rights of the individual
77	5.8 Consent directives 5.9 Consent is related strongly to purpose of use
78	5.10 Consent to collect and use versus consent to disclose 5.11 Consent is applicable to specified data
79	5.12 Consent related to disclosure 5.13 Exceptional access
80	5.14 Challenges associated with obtaining consent 6 Consent frameworks 6.1 Giving consent
82	6.2 Types of consent sta
83	6.3 Detailed requirements 6.3.1 Express or expressed (informed) consent
84	6.3.2 Implied (informed) consent
86	6.3.3 No consent sought
87	6.3.4 Assumed consent (deemed consent) 7 Mechanisms and process: denial, opt-in and opt-out, and override 7.1 Express or expressed (and informed) denial
89	7.2 Opt-in and opt-out 7.2.1 General 7.2.2 Opt-in 7.2.3 Opt-out 7.3 Override 8 Minimum data requirements
91	Annex A (informative) Consent framework diagrams
97	Annex B (informative) Jurisdictional implementation examples
101	Bibliography