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  1. FHIR Specification Feedback
  2. FHIR-28851

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive with Modification
    • Icon: Highest Highest
    • US Da Vinci HRex (FHIR)
    • current
    • Clinical Interoperability Council
    • Security and Privacy
    • 5.3 Security Labels
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      We're referencing ONC because there were past requirements in place that no longer hold and we want to draw attention to that.  CMS has never had guidelines related to this topic, so there's really no reason to reference them.

      We will revise the existing section as follows:

      "While past ONC regulations did have optional rules for data labeling and consent directives, as of May 2020, ONC has elected to not establish rules for either data labeling and consent directives..."

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      We're referencing ONC because there were past requirements in place that no longer hold and we want to draw attention to that.  CMS has never had guidelines related to this topic, so there's really no reason to reference them. We will revise the existing section as follows: "While past ONC regulations did have optional rules for data labeling and consent directives, as of May 2020, ONC has elected to not establish rules for either data labeling and consent directives..."
    • Marti Velezis / Jimmy Tcheng : 6-0-1
    • Clarification
    • Non-substantive

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      Existing Wording:

      As of May 2020, ONC has elected to not require either Data Labeling or Consent Directives as part of the Final Rule for the 21st Century Cures Act.

      Proposed Wording:

      1. As of May 2020, ONC has elected to not require either Data Labeling or Consent Directives as part of the Final Rule for the 21st Century Cures Act. While CMS regulation does not include a Data Labeling or Consent Directive specification, it does require payers to ensure their Patient Access API provides access to patients in accordance with applicable privacy law.

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            celine_lefebvre Celine Lefebvre
            Celine Lefebvre
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