Comments by Zeynep Sumer Posted on January 31, 2008

Although GNYHA's many provider members face varying issues and as a result have differing perspectives on parts of the HISPC recommendations, GNYHA recognizes the benefits of a statewide policy on patient consent to provide guidence to RHIOs. Such a policy will help ensure interoperability, earn patient trust and define and clarify existing patient consent laws. GNYHA appreciates being a stakeholder in the process of developing these policies and believes that these recommendations are a positive step towards improved quality, cost and outcomes in patient care.

Page # Line # Comments/Criticisms Suggested Alternatives
24 35 Clarification needed on how the HIPAA authorization form may be combined with the standard RHIO consent form. Specifically, will NYS DOH be providing separate combined forms for different levels of use (i.e., sensitive health information)? N/A
24 43-44 A part of true informed consent should be alerting the patient that information which was previously accessed will remain in the patient's record, even after consent is revoked. Add language to the standard RHIO consent form states that information which was previously accessed will remain in the patient's record after consent is revoked.
23 36-37 The recommendation, as stated, can be interpreted to mean that an individual provider may withhold specific information from the patient record while submitting other patient information into the record. If this is the case, then future providers who access the patient's record may be unaware of omissions or filtered information from the record and in turn may be unable to deliver appropriate care. The recommendations in this paper envision a system in which any time a provider uploads patient information to the RHIO, that patient's information is complete. This requires patient and provider education on proper use of the RHIO and gaining consent from patients. The language should be clarified to suggest that providers may not withhold pieces of the record.
22-23 41-43 1-20 Research that currently requires no patient consent and that receives an Institutional Review Board (IRB) waiver to be conducted may be more appropriately considered a Level 1 use of data. This research generally includes retrospective chart reviews, goes through a rigorous review by each provider's IRB and is granted permission to be conducted without a requirement to notify the patient of the study. Therefore, requiring consent for IRB-waived research would add an unnecessary consent requirement to the process and would prevent RHIO participants from gaining the full benefits of health information exchange. Modify the description of Level 2 uses of patient data to ungroup data for research from data for marketing and either bundle with Level 1 uses or create three distinct levels of use -- Level 1: Treatment/Quality; Level 2: Research; Level 3: Marketing. In addition, require RHIOs to have a policy and procedure that specifies what types of studies IRBs will review and the mechanisms for organizations to opt-out of specific studies.
    Please add guidance on consent rules for children and patients who have lost decision-making capacity, as well as how to reverse custodianship of patient information and decision-making once the patient regains control. N/A