Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-37243

concerned about liability implications of digital signatures

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Highest Highest
    • US Da Vinci CDex (FHIR)
    • 1.1.0-ballot [deprecated]
    • Patient Care
    • STU
    • Signatures
    • 4.04
    • Hide

      Rewrite introduction to signature to focus on the transactiond refer the reader to the payer and legal team for questions reqarding legal liability associated with sharing and signing data. add footnotes referring to a CMS regulations re signatures.

       

      Rewrite section 4.0.1 from:

      There is a legal liability associated with the data exchanged. Because of medical legal issue surrounding administrative transactions, there is a difference in the clinical vs contractual vs legal uses of data. Some data consumers may require that the data they receive are signed. For example, Medicare requires that services provided/ordered/certified be authenticated by the persons responsible for the care of the beneficiary in accordance with Medicare’s policies.1 Signatures attest that the data has been reviewed and the information is accurate and is known to be true.

       

      In addition legal claims of fraud, waste and abuse requires extensive review of logs. Therefore accurate and complete logs of what was data was exchanged must also be kept.

      to: 

      Payers may require signatures from Providers to attest that the information being exchanged is true and accurate. For example, in order for a CMS worker to adequately review a provider’s claim, the submitted information needs to be signed.(footnotes)  In direct query transactions where there is no human intervention, Payers may require signatures from Provider organizations attesting that they supplied the information. To comply with these signature requirements,  this page documents how to create and verify FHIR Digital Signatures when using CDex Transactions. Consult with your payer and your legal team for questions regarding legal liability associated with sharing and signing data.

       

       

      1. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Signature_Requirements_Fact_Sheet_ICN905364.pdf
      2. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c03.pdf#page=44
      Show
      Rewrite introduction to signature to focus on the transactiond refer the reader to the payer and legal team for questions reqarding legal liability associated with sharing and signing data. add footnotes referring to a CMS regulations re signatures.   Rewrite section 4.0.1 from: There is a legal liability associated with the data exchanged. Because of medical legal issue surrounding administrative transactions, there is a difference in the clinical vs contractual vs legal uses of data. Some data consumers may require that the data they receive are signed. For example, Medicare requires that services provided/ordered/certified be authenticated by the persons responsible for the care of the beneficiary in accordance with Medicare’s policies. 1  Signatures attest that the data has been reviewed and the information is accurate and is known to be true.   In addition legal claims of fraud, waste and abuse requires extensive review of logs. Therefore accurate and complete logs of what was data was exchanged must also be kept. to:  Payers may require signatures from Providers to attest that the information being exchanged is true and accurate. For example, in order for a CMS worker to adequately review a provider’s claim, the submitted information needs to be signed.(footnotes)  In direct query transactions where there is no human intervention, Payers may require signatures from Provider organizations attesting that they supplied the information. To comply with these signature requirements,  this page documents how to create and verify FHIR Digital Signatures when using CDex Transactions. Consult with your payer and your legal team for questions regarding legal liability associated with sharing and signing data.     https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Signature_Requirements_Fact_Sheet_ICN905364.pdf https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c03.pdf#page=44
    • Eric Haas/Bob Dieterle: 8-0-3
    • Clarification
    • Non-substantive

    Description

      We are concerned about liability implications of digital signatures, for example in a situation where a piece of information is inaccurate but not the responsibility of the physician who submitted the digital signature (i.e., the physician signing is not the physician who collected and recorded the information). We recommend adding a note flagging these concerns for implementers.

      Attachments

        Activity

          People

            Unassigned Unassigned
            celine_lefebvre Celine Lefebvre
            Molly Reese (Inactive)
            Watchers:
            3 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: