Comments by Barbara Radin Posted on January 31, 2008

Page # Line # Comments/Criticisms Suggested Alternatives
18 13

The proposed model for consent to access at every provider is in conflict with the stated goal of having an informed consent. For consent to access to be at a level that is meaningful to a patient, it should really be at the individual provider level. To put it at the organizational or institutional provider level makes it extremely difficult for a truly informed consent to take place and has great potential for patients to include or exclude providers without really understanding they are doing so. To create information on who belongs to what organization will be an expensive endeavor for RHIO's that include hundreds of locations that may be grouped in multiple organizations. It will also create confusion and expense as entities break apart and merge. Because implementing an individual provider level access control is complicated and expensive it is recommended that this be phased in over a longer time period to give RHIO's a chance to get started and get some experience with consumer reaction to the concept of information exchange.

Having an affirmative consent to share or not share information through a RHIO provides the protection that is needed in the interim and will make it very clear for the patient what the options are. Patients who do not wish to share data with a "provider" can be counseled not to participate for now.

Requiring that a consent be collected at each provider location creates new cost to the health care system. The goal, to be sure that the consumer is aware of and gives consent for each organization which will be granted access, can be accomplished with less paperwork and less need for additional work for providers staffs. It will also be less burdensome and confusing for consumers who will not be repeatedly asked for consents. Allowing one organization to explain access to information and obtain consent on behalf of multiple participants in the RHIO is dependent on the trust built within the RHIO.

Option 1: preferred option, Each RHIO must obtain an affirmative consent from the consumer that specifically references the RHIO and all its participants.

Option 2: Each RHIO must obtain consent for access on behalf of each participating organization, by obtaining at least one affirmative consent that specifically references the RHIO and each participating organization. RHIO's may require a separate consent be signed at each organization.
20 29 Same as above. Should be noted that the significant additional ongoing cost being built into the system with this option should be accounted for in the cost benefit analysis. Each RHIO must obtain consent for access on behalf of each paricipating organization, by obtaining at least one affirmative consent that specifically references the RHIO and each participating organization.
20 40 Should be made consistent with above RHIO's must comply with minimum consent standards set by the state and use a state approved consent form.
23 1 to 10 Research and Marketing are very different and should not be considered at the same level. In developing this level further it is important to distinguish between activities which have potential value to society from those that are purely of a financial value. Consider adding marketing to non permitted uses of data. Convene a group that has more researcher representation to consider research issues.
23 36 It will be extremely difficult to withhold information from an electronic exchange without withholding from the local EMR. This should be a RHIO level policy. Change "must" to "may"
24 40 thru 44 Under the recommended model, consent to access is granted at each provider location and would have to be revoked at each provider location. This is highly impractical if for instance I learn that I have a genetic test result that leads me to decide I don't want my information accessed by anyone other than my specific doctor and have previously signed consent for access to my data at 6 provider sites. I now have to contact each of those sites to revoke their access. Specifically allow revocation for all sites at one site.
29 18 Patients who are active members of health plans already sign consent granting access to their medical information wherever it resides. Asking for an extra consent seems to be an unnecessary bureaucratic burden and cost. Use existing health plan consent for health plans that are participants in RHIOs.
30 31 The most efficient and effective solution for allowing RHIO to RHIO communication across multiple RHIOs has not yet been determined. One of the functions of the NYeC RHIO committee and the NHIN projects is to do the exploration of the issues with all the RHIO's and vendors and determine the best solution the allows the best use of resources. To put a solution in place at this time that will mandate one prescribed solution which in the end may have to be changed and may ended up wasting scarce resources. Change in language here would be based on change in policy but should speak to the need to develop a uniform policy that is efficient and effective and the role of NYeC in that process.