Comments by Tom Check Posted on January 31, 2008

The standardarized State-wide policies proposed in the HISPC White Paper facilitate the important public policy goals of HIE, respect decision-making by consumers, acknowledge the practical abilitites and limitations of RHIOs, enable a consistent State-wide program for consumer awareness of HIE, and allow RHIOs to exchange data for the benefit of patients in common with an assurance that it will be accessed and used appropriately. These policies will benefit all residents and providers in New York State.

Page #	Line #	Comments/Criticisms	Suggested Alternatives
20	20	Seems to be a typo.	At the end of the line, change "reporting, clinical" to "reporting and clinical".
22	11 through 34	Prior to RHIOs, a provider organization can be authorized by its Institutional Review Board (IRB) to conduct specific research studies entailing retrospective chart reviews, waiving both HIPPA authorization and written informed consent by the patient. Each provider organization's IRB currently follows strict standards as to the conditions under which a retrospective research study can qualify for this "IRB waiver," and the IRB grants or denies a waiver to each such study individually. These standards ensure that the study poses no risk or very minimal risk to the patient, and the waiver is granted only when obtaining explicit consent from the patient for this individual study would be impractical. With the formation of RHIOs, it will similarly be possible for provider organizations to conduct joint studies entailing a retrospective review of data of the participating providers collectively. While this sometimes occurs now in ad hoc agreements among providers for specific studies, RHIOs provide the opportunity to expand the benefits of this type of research.	Modify the description of Level 1 uses to include IRB-waivered retrospective research. The RHIO would need to develop and maintain policies and procedures that define which IRB(s) will review the research design and grant the waiver, what guidelines they will follow in doing so, and how the provider organizations in the RHIO will be notified of the research so they can decide whether to allow patient data from their facilities to be included. The first IRB-waivered retrospective review the typical RHIO will perform is the evaluation of its own results as required by the HEAL program. Another such use is when the IRB permits the researcher to search the database to identify potential study subjects for a prospective study, after which the researcher requests the patient's provider to obtain the patient's written informed consent to enroll in the study. The availability of IRB-waivered retrospective chart reviews across multiple providers will provide many more opportunities to advance the goals of the SHIN
22	36, 37	The restriction that "Any entity accessing information must have a relationship with the invididual who is the subject of the information and the information must pertain to such relationship" should apply to Treatment and to Quality Improvement and Disease Management, but not to IRB-waivered retrospective chart review as described above.
22	42	Although "Level Two uses include research," IRB-waivered retrospective chart reviews, as described above, would be a Level One use.
23	36, 37	Page 28, lines 22 through 28, make clear that the provider organization will establish a policy of how it will protect sensitive data for all of its patients, and how it will engage patients in these decisions. As worded, page 23, lines 36-37 can give the impression that an individual clinician may decide to withhold specific information from the patient's record while including other information. This has the potential of making it more difficult for a subsequent clinician to deliver appropriate care because he or she will be unaware of the omission and may believe the record to be more complete than it is.	A suggestion for alternate language for page 23, lines 36-37 is: "Provider organizations that offer the ability to screen sensitive information should provide guidelines to their clinicians as to how to counsel patients on health information exchange so that the patient can make an informed decision within the options available under the provider's policies."
23	41, 42	Modify this sentence to make it clear that if the provider shares data with other RHIOs as of the time it obtains the patient's consent, it must inform the patient at the time of consent (as in page 23, lines 39 through 41), but that if the provider begins to share data with other RHIOs subsequently, the provider must make that information available to the patient as described on page 24, lines 1 through 4.	A suggestion for alternate language for page 23, line 41 through page 24, line 3 is: "If the RHIO has entered into contractual arrangements to share data with other RHIOs, then at the time of consent, consumers must be informed of the RHIOs with which it shares such information. Consumers must also be informed that the providers participating in this RHIO, and the RHIOs with whom this RHIO exchanges data, will change over time, and at the time of consent the consumer must be given instructions on how to learn about those changes."
26	21 through 23	Because "audit trail" has many meanings, modify this sentence to make clear what meaning is intended here.	A suggestion for alternate language is: "RHIOs and their participants must make available to the consumer upon request an audit trail or an "accounting of disclosures", specifying which individuals at which provider organizations have retrieved the consumer's health information through the RHIO, and at what dates, including but not limited to disclosures for treatment, payment and health care operations and those specifically authorized by the patient. However, once an individual has retrieved data from the RHIO and copied it into another record, it is not possible for the RHIO to tell the consumer who may have viewed the data from that record."