PiP Overview

Since the launch of Markle Connecting for Health in 2002, a nationwide, interoperable, private and secure health information sharing environment has become widely recognized as necessary for achieving high quality health care. Such an environment—in which information is available to enable each participant to make better health and health care decisions—holds promise for dramatic improvement in the quality and cost-effectiveness of care.

Those implementing health information sharing efforts¹ quickly learn that achieving such a health information sharing environment for high-quality, cost-effective care will require trust. A recent survey commissioned by the Markle Foundation found that the privacy of health information is a significant concern for the American public and for doctors. Overwhelming majorities of both groups expressed concerns about privacy and support privacy-protective practices, such as letting people see who has accessed their records, notifying people affected by information breaches, and giving people mechanisms to exercise choice and to correct their information.²

The Markle Connecting for Health Common Framework for Private and Secure Health Information Exchange (Markle Common Framework), published in 2006, describes a threshold set of policy and technology practices for health information sharing to establish core privacy principles, sound network design, and accountability and oversight while supporting variation and encouraging innovation. A diverse group of health care leaders developed the principles, policies, and practices of the Markle Common Framework based on U.S. Fair Information Practice Principles (FIPPs) to lay a blueprint for an integrated and comprehensive framework of trust.

The Markle Connecting for Health Common Framework Policies in Practice for Health Information Sharing (Policies in Practice) is an addendum to the Markle Common Framework. The Markle Common Framework schematic shows a visual representation of the relationship of these Policies in Practice resources to the original Markle Common Framework. The Policies in Practice were developed through a collaborative process by a diverse group of health care leaders with hands on experience implementing health information sharing efforts, including state health IT leaders, legal experts, technology experts, and consumer representatives. This compendium of practices further specifies the Markle Common Framework to address a range of critical implementation needs for health information sharing in today’s rapidly changing environment.

The Policies in Practice address the following areas:

• Key Laws and Regulations: Changes Relevant to the Markle Common Framework. Highlights modifications to relevant privacy laws over the last five years and addresses them in the targeted policy areas of the Markle Common Framework.
• Consent: Implementing the Individual Participation and Control Principle in Health Information Sharing. Provides context for implementing the privacy principle of Individual Participation and Control and suggests ways for health information sharing efforts to establish their own policies and best practices.
• Individual Access: Connecting Patients with Their Health Information. Identifies and specifies opportunities for addressing individual access and engagement in relation to health information sharing.
• Governance of Health Information Sharing Efforts: Achieving Trust and Interoperability with Meaningful Consumer Participation. Clarifies the objectives of governance, detailing attributes of governance processes and providing specific guidance with respect to the role of consumers.
• Policy-Aware Procurement Strategies and Practices: Asking the Right Questions and Reaching the Right Answers. Details important elements to apply in technology procurement efforts, so that required policies are part of the acquisition and implementation of technology.
• Mechanisms for Oversight, Accountability, and Enforcement: The Model Contract Update and More. Identifies issues and decisions for data-sharing agreements and other policy development related to oversight and accountability, and updates the Model Contract resources, M-1 and M-2, in the context of new federal and state laws and implementation requirements.
• Frequently Asked Questions. Provides answers to frequently asked questions about the Markle Connecting for Health Common Framework.

This document provides an overview of the Policies in Practice. It describes some of the key changes in the health information sharing landscape since 2006, outlines some of the needs that led to the Policies in Practice, and describes the Policies in Practice, along with their key premises. For those unfamiliar with the Markle Common Framework, this overview document provides direction on how to begin considering and applying the Markle Common Framework.

Why were the Policies in Practice resources developed?

The health information sharing landscape has changed dramatically since release of the Markle Common Framework in 2006. Over recent years, the level of federal leadership, new regulation, and public investment around health information sharing have increased substantially. In addition, use of health IT has grown among providers and individuals alike.

Early efforts to establish an infrastructure for health information sharing were bolstered in 2004 through an Executive Order which established the Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) and made possible efforts for standards harmonization, use case development, and the certification of electronic health record (EHR) products. By 2006, the health care sector was struggling to overcome challenges of policy, technology and capital investment to advance health information sharing.

In response to many of these challenges, Markle Connecting for Health released the Markle Common Framework in 2006, setting forth foundational policies and practices for health information sharing to improve health and health care, while protecting privacy and security and encouraging innovation. A diverse group of leaders with expertise in health care delivery, technology, privacy and the consumer experience developed the Markle Common Framework through a collaborative effort.

As health information sharing has matured, new lessons and additional challenges have emerged. Interviews conducted by Markle with health information sharing leaders across the country identified an initial set of high-priority resource needs to support current health information sharing efforts.³ A planning group,⁴ followed by the establishment of the Markle Connecting for Health Health Information Exchange Advisory Committee (Markle HIE Advisory Committee), convened to refine this list of priorities and to develop complementary resources.

The result is this set of Policies in Practice resources, developed through a collaborative process, which aim to meet the needs identified by implementers. The Policies in Practice build on the Markle Common Framework and are intended to provide further detail for health information sharing efforts, regardless of their funding source, demographics, or governance structure. Given the varying needs of decision makers and the complex issues involved, each Policies in Practice takes a unique approach, using questions and answers, tables, crosswalks, and step-by-step guidance to serve as a useful resource for the issue at hand.

What are some key premises of the Policies in Practice resources?

The Policies in Practice are an adjunct to the Markle Common Framework, not a replacement. Each Policies in Practice document aims to further specify the Markle Common Framework, to address a range of prioritized implementation needs, identified by the outreach done in the planning phase and the Committee.

The Policies in Practice are not toolkits or stand-alone solutions. The elements of the Markle Common Framework and the Policies in Practice focus only on attributes that are minimally necessary for interoperability of technology and policy, to support trusted information sharing at the national level, while allowing for state, regional, and local variability. They should be considered together and used in context, complying with all relevant federal and state laws and regulations, and in light of current operations and objectives. The Key Laws and Regulations: Changes Relevant to the Markle Common Framework Policies in Practice provides insight on how relevant privacy laws have changed over recent years.

A set of clear and explicit health goals is essential for any health information sharing effort. A successful 21st century health information sharing effort cannot be achieved by policy and technology alone. It needs to meet the community’s goals as it serves both the personal care setting and public needs and values. Specific goals for health improvement and for cost-effectiveness must be clear and explicit, subject to public discussion, and architected into policy and technology at the outset. Without clear goals, health information sharing efforts risk becoming an exercise in process and reporting, rather than an opportunity to improve health and efficiency. All participants in the effort should support these goals.

Health information sharing does not equate with access to complete health information. Although electronic storage and sharing holds promise in improving access to health information, many limitations of the paper medical record environment will persist in an electronic environment. Individuals may not know or have access to all the places that hold their information; information may be lost or unavailable; and individuals can withhold information from their providers or ask that certain information not be shared. Even in an electronic environment, providers and patients alike should be educated on the likelihood and consequences of incomplete information.

Conclusion

While public and private sector initiatives have been important to advancing widespread, trusted health information sharing, the need for a complete “framework” remains. The Markle Common Framework is one such framework, created to offer a comprehensive set of policy and technology attributes to establish a trusted health information sharing environment.

In developing the Policies in Practice, we recognize that the health information sharing environment is constantly changing. As policy, technology, and health information sharing needs and capabilities continue to evolve, it is critical to incorporate new knowledge and lessons learned. The Policies in Practice are a compendium of resources that are designed to further specify, clarify and update the Markle Common Framework to help those implementing health information sharing efforts realize the nationwide, interoperable, private, and secure health information sharing environment necessary for achieving high quality, cost-effective health care.

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1. The Policies in Practice apply the term “health information sharing effort” broadly to refer to any initiative that supports the electronic exchange of health information between data holders. Similar terminology includes “health information exchange (HIE),” “regional health information organization (RHIO),” and “sub-network organization (SNO).”
2. Markle Health in a Networked Life, “The Public and Doctors Overwhelmingly Agree on Health IT Priorities to Improve Patient Care,” Markle Foundation, last modified January 31, 2011: http://www.markle. org/publications/1461-public-and-doctors-overwhelmingly-agree-health-it-priorities-improve-patient-care (accessed on February 22, 2012).
3. Interviews were conducted between July 2010 and October 2011 with nearly 20 health leaders involved in health information sharing efforts.
4. Planning group members: Phyllis Albritton, Colorado Regional Health Information Organization (past); Allen Briskin, Pillsbury Winthrop Shaw Pittman LLP; Carol Diamond, Markle Foundation; Vicki Estrin, C3 Consulting, LLC; Liza Fox-Wylie, Colorado Regional Health Information Organization; Gerry Hinkley, Pillsbury Winthrop Shaw Pittman LLP; Ted Kremer, Greater Rochester Regional Health Information Organization; Alice Leiter, National Partnership for Women and Families; Linda Malek, Moses & Singer LLP; Deven McGraw, Center for Democracy and Technology; Amanda Parsons, New York City Department of Health and Menta l Hygiene; David Patterson, South Carolina State Budget and Control Board; Jan Root, Utah Health Information Network; David Sharp, Maryland Health Care Commission; Marcy Wilder, Hogan Lovells; Claudia Williams, Office of the National Coordinator for Health Information Technology.