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January 18, 2005 

 

David Brailer, MD PhD
NHIN RFI Responses
US Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Hubert H. Humphrey Building, Room 517D
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Dr. Brailer:

On behalf of the National Consumers League (NCL), I am pleased to submit this response to the request for information (RFI) issued by the Office of the National Coordinator for Health Information Technology (ONCHIT) regarding how widespread interoperability of health information technologies and health information exchange can be achieved through a National Health Information Network (NHIN).  Please note that, while this document does not directly respond to the questions posed in the RFI, it does set forth a set of principles that should govern the design decisions for the emerging NHIN. 

The perspectives shared in this document likely will deviate from those elicited from health care institutions and commercial entities but, given the vast impact the NHIN could have on healthcare consumers – either as an innovation that positively transforms and enhances, or as a corrosion of public trust – we hope that you will give this perspective thoughtful consideration.  As an organization committed exclusively to representing consumer interests, NCL is well positioned to offer guidance that will assist ONCHIT in coordinating the development of a modern system that would be widely used, trusted by relevant stakeholders, and leveraged for public health. 

Furthermore, NCL is not alone in promoting many of the principles set forth below.  While not in complete accord on all points, these principles generally reflect a consensus achieved through collaborative discussions with several consumer and patient advocacy groups, and guided under the auspices of the Markle Foundation.  The principles, segmented according to operational function, are set forth below.   

Consumer-focused Principles

1)    Information access and control

a.  At a minimum, the NHIN structure and rules must facilitate the ability of people to exercise their personal health information rights under the Health Insurance Portability and Accountability Act (HIPAA).

b.  People must have the ability to control who has access to/permission to use their personal health information over the network – either directly or through the action of a designated proxy [or by choosing not to exercise that control].  This control can be exercised in whole or only with regard to selected types of data elements, but the decision to share should be made without coercion or pressure.

i    If people fear inappropriate disclosure and do not trust the network, they may become less willing to seek care or provide consent to share even that information to which they otherwise would allow access.

c.  People should have the ability to review accesses made to their personal health information.  Each individual or entity accessing personal health information over the network should possess a unique digital signature, through which patients can have access to a standardized profile of the entity or individual reviewing their PHI.

d.  No personal health information should be available to a provider or health professional that is not also available to the person it describes (with exception for cases of danger to the patient).  

e.  Unreasonable or unaffordable fees should not impair the ability of each person to review or contribute to their personal health information on the NHIN.   

f.  People must be able to, at their liberty, add comments or annotations to their personal health information.

g.  People must be able to request amendment or correction of their personal health information and receive a timely response to the request. 

h.  The NHIN must provide a sound method for allowing secure access and authenticating individual patient users that does not require physician or institutional mediation.  

i.  People must have the ability to designate (and withdraw designation from) proxies who have full authority to manage their personal health information on the network.

2)    Disclosure and accountability

a.  Before a provider initiates a transfer of personal health information through the exchange, affected individuals should fully understand the policies in place and the possible uses of that information.  (First-time disclosure is sufficient for subsequent transactions, so long as the patient has the ability to change “default settings” at any time (see point 1 i.)) 

b.  Information elements central to network functioning, such as identifiers, authorizations and permissions, access histories, and index entries, must be presented in easily understood terms and formats to patients, consumers, and other authorized users for their review and possible correction or control. 

c.  People should be informed of all of the possible ways their information may be used and must be able to choose whether to make their personal health data available for such use in various systems.  Clarification note: the NHIN must permit for distinction between data storage and data use.  For logistical reasons, maintaining all patient information in the network may prove necessary.  However, all stakeholders need to understand that, just because data are physically available, this does not necessarily mean they can be accessed for use.   Point 1b. under “Access and Control” would apply.  

d.  Communications with people about the policies and uses of their information in the exchange must be conducted in simple, easily understood language.

e.  States should adopt common operating standards for data security and patient privacy protection, including established clearly described penalties for violations not covered by HIPAA (such as identity theft), and an accountable means for violation monitoring and prosecution.

f.   People must be able to receive complete paper copies of any of their information available across the national network.

3)    Functionality

a.  The NHIN must provide the capability for people to reliably and securely move all or portions of their personal health information from one health care entity to another.

b.  The NHIN should permit the aggregation of non-identifiable data in support of quality measurement, provider and institutional performance assessment, prescription drug monitoring, patient safety, public health and other public interest objectives.

c.  Non-identifiable data sets generated from the NHIN should not be used for insurance underwriting or other commercial applications intended to provide preferential pricing or services to one group over another.  Preferential pricing would not include differential payment to providers in recognition of quality performance.

d.  Implementation of NHIN must be accompanied by a significant public education program so that people understand the value of the network, its privacy and security protections, how to participate in it, and the rights and benefits afforded to them.

e.  The NHIN must permit patients to transmit information to their health care providers as well as receive information from them. 

4)    Governance

a.  Consumer and patient advocates must have significant representation in the governance and advisory structure of all regional and national NHIN authorities, including standard-setting and operational entities.

b.  The governance and administration of the NHIN must be public, transparent, and accountable.

 

In considering these principles, NCL suggests that you view them in their totality, as removing even one of these critical components could have serious implications for the integrity of the system as a whole.  For example, elimination of point 1b would completely undermine consumer trust in the network, and likely result – in many cases – in reluctance to seek necessary care. 

Thank you for allowing us the opportunity to comment on this issue.  As you embark on implementation efforts, we look forward to working with you to make sure that these principles are integrated into the NHIN.

Sincerely,

Linda Golodner
President, National Consumers League