Comments by New York Chapter, American College of Physicians Posted on February 1, 2008

January 31, 2008

To: HISPC Committee, NYeC, NYS DOH

Regarding: RHIO Patient Privacy and Consent policy for NYS

The New York Chapter, American College of Physicians (NYACP) has several important concerns and reservations about the white paper document dated December 21, 2007, entitled "Standardized Consumer Consent Polices and Procedures for RHIOs in New York State".

Two of the seven recommendations listed on page 18 should be addressed promptly and improved so as not to impede this important project.

Recommended Policy #2:

Affirmative Consent – each provider organization…must obtain an affirmative consent from the consumer…prior to accessing his/her health information.

This recommendation outlines a process whereby affirmative consent would be required of each physician (or provider organization if a group practice is involved) as well as each patient in order for active information exchange to take place. We feel very strongly that this would be a damaging, unnecessary, and counterproductive policy if adopted in this format. The reasons for our concerns are many.

First, there is an extraordinary burden placed on providers -- solo practitioners, community health centers, institutions, medical group practices as well as RHIOs if they become saddled with this vast administrative burden. The process of educating patients with respect to the consent policies that are outlined (often duplicating work already done in other provider offices), keeping track and maintaining the records of such consents, and appropriately sorting and selecting patients in these different consent categories is a complex task that will reach all aspects of the New York health care system. It adds tremendous administrative load and expense throughout healthcare in our state, and will add extra administrative cost and overhead to the system and markedly increase administrative complexity. By definition, the activities undertaken by each provider to educate patients will soon become redundant and duplicate work that has been done by others before, highlighting the administrative complexity of the system as it is described, and perpetuating administrative redundancy in perpetuity. The very sophisticated and subtle nature of the high degree of patient understanding implied in this white paper would be especially challenging to achieve, and would commensurately increase cost and complexity further. This item directly leads to a second concern.

The process as outlined will disenfranchise some of the neediest and sickest members of our population. The document envisions an informed, high-level, analytical consent based on knowledge of privacy, confidentiality, and internet exchange that is certainly within the purview of some of our most knowledgeable and educated New Yorkers. However, many of our patients -- particularly those most in need of the benefits of enhanced and liquid health information interchange -- do not have such knowledge. There are large subsets of our population with limited cognition, low health literacy, minimal computer and internet familiarity, barriers to the healthcare system, and spotty and erratic access to health care. The process as outlined would make it most difficult for these people to benefit from a system that relies on a high level of knowledge and understanding to give the type of affirmative consent that this policy requires. It is almost discriminatory in the type of differentiation it makes amongst our New York state population. If the forms and processes are too complicated for patients and providers, then the patients will feel obligated to sign the form simply because they trust the provider and not because they understand the consent process. And providers will find that this is simply the only way to make the process work. We represent all New Yorkers and feel it is just as important to consider our vulnerable patients, not just our most medically sophisticated.

Thirdly, the document definitively refers to the value and necessity of the system having high liquidity. The paper describes on page 19, lines 4-19 what liquidity is and why it is so important. We strongly agree that high liquidity is needed for the system to be utilized by providers and to be effective in improving patient care and improving patient outcomes, as well as avoiding duplicative and unnecessary testing. By requiring affirmative consent, this system becomes illiquid and all those benefits are lost. A system of affirmative consent would by definition exclude a large (but not measurable) portion of our NYS population. It would effectively discourage providers from participating fully in utilizing these systems, because the fewer patients enrolled the less utility this will provide in the office where care is delivered. The patient care benefits for everyone drop off rapidly the greater the number of patients and providers who do not participate. The white paper already addresses the potential value of a robust system on page 4, lines 6-20, but unfortunately then goes on to recommend a policy (above) that seriously hinders this potential. We encourage eliminating this recommendation to be consistent with these points already addressed so well in this paper.

Fourthly, the document refers to consumer trust and consumer confidence. It is our position that consumer trust and consumer confidence is enhanced and assured by building the system with the proper guidelines, requirements, audit features and review policies and not by building a "better consent form". The trust of the consumers will be responsibly and convincingly addressed when operational effectiveness and appropriate safeguards are in place -- not by a new and better form. There is also little precedent in current NYS Health Information practice that identifies serious problems in existing operations such that draconian corrections are now needed. As one example, currently there are two community-wide information systems widely used throughout the Buffalo area. They are operated by the two large health systems in the area and are not interoperable with each other since there is not yet a functioning RHIO able to interconnect these two systems at this time. Nonetheless, years of operating these two systems throughout a large community without requirements of affirmative patient consent has led to no issues with consumer confidence, known problems or difficulties with privacy or security problems, or any other pertinent concern. It is clear from the microcosms of local experience throughout the state that systems are liquid without affirmative consent, patient acceptance is extraordinary, and patient complaints or concerns are not being seen.

Most physicians in practice have a vastly different view of patient concerns than those described in the white paper. Currently patients expect that testing and results and information about them are already available to their treating physicians. Responses range from angry to frustrated to resigned when they realize that the current antiquated medical information system is incapable of delivering information the way their consumer commercial transaction systems have for many years. The vast majority of patients do not fear the development of interoperable RHIO information – they welcome it and cannot understand why it has taken so long. This view has not been sufficiently vetted in the analyses to date and is vitally important to the understanding of the current office and hospital practice of medicine.

Recommended Policy #5: Sensitive health Information – a single consent may be obtained to exchange all health information, including all specially protected health information.

The reason we object to this is that this recommendation insisting that all health information be saddled with the very severe restrictions of sensitive health information is unnecessary, does not enhance the delivery of health care to our New York state residents and impedes the liquidity and utilization of the system by requiring all information to be treated the same way. There is no sound rationale to restricting "general" health information in the same way sensitive health information needs to be limited.

On a practical matter, the vast majority of clinical information, which is everything other than the defined "sensitive" areas, would provide almost all if not all of the benefits the position paper describes on page 4. We feel it is open to further discussion whether all sensitive information needs to be included in the RHIOs. The significant benefits will accrue with all the other medical information.

Alternative Operational Model

In fact, the document describes on page 19 an exception policy which it describes as applying to "one-on-one" electronic health information exchange. This recommendation, which in this document is limited to one specific type of transaction, would serve as an effective model for how the electronic health information exchange throughout New York State RHIOs should take place for all information other than sensitive health information.

Our Recommended Solutions:

Eliminate recommendation #5:

requiring a single consent form for all health information including all specially protected health information. A single statewide consent form should be developed with applicable current laws. A consent form should be required only for sensitive heath information.

Eliminate the requirement for affirmative consent for all patients limiting affirmative consent to the sensitive health information for which it is legally required.

Use the process described on page 18, lines 28-38, as a model for the operational process of information exchange of non-protected medical information for the RHIOs in New York State.

Respectfully Submitted,

Stephen Peterson, MD, FACP
NYACP President
Hudson Valley Governor

Edward A. Stehlik, MD, FACP
NYACP Upstate Governor

Joseph Fins, MD, FACP
NYACP Downstate I Governor

John Maese, MD, FACP
NYACP Downstate II Governor

Michael D. Ammazzalorso, MD, FACP
NYACP Downstate III Governor