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The document you are reading is part of the Markle Connecting for Health Common Framework for Private and Secure Health Information Exchange (Markle Common Framework). The Markle Common Framework includes a set of foundational policy and technology guides published in 2006. In April 2012, a set of Policies in Practice was published to further specify these foundational documents and address a range of critical health information sharing implementation needs identified by experts working in the field. |
How does the Markle Common Framework apply Fair Information
Practice Principles?
How does the Markle Common Framework support population health
activities?
Does the Markle Common Framework address the sustainability of health
information sharing efforts?
What is the Markle Common Framework’s network approach?
How has the landscape changed since release of the Markle Common
Framework?
How does the Markle Common Framework align with state and federal
efforts?
How does the Markle Common Framework for Private and Secure Health
Information Exchange relate to the Markle Common Framework for
Networked Personal Health Information?
Appendix A
The following are answers to frequently asked questions about the Markle Connecting for Health Common Framework for Private and Secure Health Information Exchange (Markle Common Framework).
Information sharing depends on trusting relationships among entities and institutions, not machines. Our experience suggests that any health information sharing effort1 must adopt a framework of trust and then translate it into practice by specifying the policies, practices, and technology choices necessary for implementation. The specific policies and practices of the Markle Common Framework benefited greatly from their grounding in nine policy principles from the U.S. Fair Information Practice Principles (FIPPs)2 and the Organization for Economic Cooperation and Development’s (OECD) Guidelines Governing the Protection of Privacy and Transborder Flows of Personal Data.3 In the U.S., FIPPs have been recognized for decades at the state and national levels. Recently, both the Commerce Department and the Federal Trade Commission have recognized FIPPs as important foundational elements of a nationwide privacy framework to address privacy in a digital age.4, 5
Based on FIPPs, the Markle Common Framework policy principles include openness and transparency, purpose specification, collection limitation and minimization, use limitation, individual participation and control, data integrity and quality, security safeguards and controls, accountability and oversight, and remedies.6 No single principle is adequate on its own. Meaningful safeguards are achieved by applying these principles together: applying some and not others can weaken the overall approach. In Appendix A, we provide tables that identify how the Markle Common Framework Policy and Technology Guides and the Policies in Practice address each of the core policy and technology principles.
As health information becomes increasingly networked, opportunities are growing to support health and health care not only for individuals, but for entire populations as well. Aggregation and analysis of population-level data can address important research questions related to quality, clinical effectiveness, public health, and safety. The Markle Connecting for Health First Principles for Population Health Data Sharing and Decision Making apply the key attributes of the Markle Common Framework to population health initiatives. The First Principles emphasize a distributed “network of networks” approach where data on individual patients remain with local data holders, while only summarized, anonymous data are aggregated for large-scale analysis. The First Principles outline an initial set of policy and technical principles to enable broad-scale information sharing, while protecting individual patient privacy.
Some technical challenges need to be addressed to allow for broad scale implementation of this model. For example, it is difficult to find and delete duplicate “anonymized” records that may be counted unintentionally in multiple summary statistics. However, there is promising research in the area of distributed models, as well as compelling examples of successful models that address a range of population health questions.7, 8 Due to the enormous potential for societal benefit, further research and development is warranted.
The Markle Common Framework is rooted in the premise that sustainability cannot be achieved unless efforts are grounded in clear and explicit health goals, and improvements in health care quality and cost-effectiveness are valued and supported.9
Although federal spending under the Health Information Technology for Economic and Clinical Health (HITECH) Act of the American Recovery and Recovery Act of 2009 (ARRA) has resulted in an unprecedented level of federal funding to foster the application of health IT and health information sharing, long-term sustainability will depend on aligning improvements in health care quality and cost-effectiveness with financial and non-financial incentives. In addition, the private sector needs to demonstrate clear and substantial support for these types of improvements in order to sustain health information sharing. A true return on investment can only be realized when this happens.
The Markle Common Framework offers an approach to information sharing that is predicated on a ‘network of networks’, like the Internet, and designed to enable health information sharing with a policy and technology framework that promotes innovation and protects privacy.
The Markle Common Framework is built on the assumption that all health information sharing decisions are best made between the patient and the provider with whom the patient has a relationship. The network of networks design is distributed, allowing information to be kept at its source and transmitted when authorized to appropriate recipients. In this model, patients and the doctors they trust can decide with whom to share personal health information and for what purposes.
‘Finding’ the location of a patient’s health information is described in the Markle Common Framework using an index called the Record Locator Service (RLS) that points users to the authorized records they are requesting. The RLS does not contain actual clinical data or clinical metadata. After identifying where the clinical information is stored, each provider holding records has the discretion to disclose those records, depending on the decisions the providers have made with their patients. Transfers of health information may then be accomplished via fax or secure e-mail, or by secure computer-to-computer transfers over the Internet, depending on the level of information sharing available. Providers and sources that routinely collaborate may exchange data automatically and electronically. Thus, there are two decisions to be made locally: whether to index and whether to share.
This two-step process helps ensure that the system does not increase exposure of personal health information, while making record location fast and efficient, even in environments where electronic records are not fully available.
Additional information on the RLS can be found in T1: The Markle Common Framework: Technical Issues and Requirements for Implementation.
As reflected in the Markle Common Framework, policies must be crafted in parallel with the design and deployment of technology and in an ongoing manner. Both policy and technology evolve with new information sharing needs and objectives, and therefore will remain important objectives.
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.
Adoption of health IT in clinical settings was weak. In 2006, only 29.2 percent of physicians reported any electronic medical record (EMR) or EHR in their office-based practice.10 (An EMR/ EHR is a medical or health record system that is either all or partially electronic, excluding systems solely for billing.) That same year, 26 health information exchanges (HIEs) reported being operational and transmitting data for use by their health care stakeholders.11
Enactment of the HITECH Act in February 2009 marked a new level of federal leadership, regulation and investment for health information sharing. Aiming to address many of the challenges facing the health care sector, the HITECH Act codified into law the U. S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC), established federal advisory committees to advise ONC on policy and standards decisions, invested in state HIE, set forth an EHR incentives program for Medicare and Medicaid providers, established new initiatives to support the education and training of the health IT workforce, modified particular aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and established new programs to foster individual engagement with health IT.
On the heels of the HITECH Act, broad-scale health care reform legislation, the Patient Protection and Affordable Care Act of 2009 (ACA), was enacted. Aspects of ACA aim to further leverage health IT in efforts to transform health care. For example, it calls for the creation of a “Shared Savings Program” to deliver seamless, high-quality care for Medicare beneficiaries through Accountable Care Organizations (ACOs), which must apply health IT in order to meet care coordination requirements.
Recent investments have recognized health IT and health information sharing as critical to improving the quality and efficiency of health care in the U.S., as reflected by rising adoption rates. Preliminary data indicate that 43.9 percent of physicians reported any EMR/EHR in their office-based practice in 2009.12 By 2011, 85 HIEs were reported to be operational.13
A recent Markle Survey on Health in a Networked Life uniquely compares the core values of physicians and patients on deployment of IT in health care. Seventy-four percent of doctors surveyed said that they would prefer computer-based means (electronic networks, secure email, or portable storage devices) to paper and fax, when sharing patient information with each other. Up to 74 percent of doctors agreed that patients should be able to share information with their doctors electronically. At least 59 percent of the public agreed with this statement. The survey results also indicate that personal health record (PHR) adoption is on the rise, with 10 percent of the surveyed public reporting having a PHR in 2010, compared to 3 percent in 2008.14
Since its release in 2006, health information sharing efforts have used the Markle Common Framework to develop architecture, specifications, and policies for the private and secure sharing of health information. Many states cite the Markle Common Framework in their operational and strategic plans to ONC as part of the State HIE Cooperative Agreement Program. States also refer to the Markle Common Framework in their online policy and technology materials.15
The Markle Common Framework is also closely aligned with federal policy efforts. For example, the EHR incentive program reflects many elements of the Markle Common Framework; setting forth minimum necessary standards to allow for flexibility and innovation within the marketplace, as well as requiring the submission of aggregate quality data to minimize risk of exposing patient data.16, 17 In the area of population health, ONC recently announced new efforts to explore and further the application of distributed networks.18
The important role of foundational principles, policies, and practices, like those of the Markle Common Framework, in supporting the trusted sharing of health information, is recognized by the federal government. For example, in March 2012, ONC released a Program Information Notice titled Privacy and Security Framework Requirements and Guidance for the State Health Information Exchange Cooperative Agreement Program that builds upon the “Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information” and sets forth guidance centered on FIPPs-based principles for states to apply in developing their privacy and security policies and practices. In addition, the Health IT Task Force, a joint initiative of the ONC and Office of Management and Budget, called for select federal agencies to coordinate health IT investments around a shared set of policy and technology principles, to maximize the benefits of health IT. In September 2010, Vivek Kundra, the Federal Chief Information Officer, and David Blumenthal, the National Coordinator for Health IT, articulated a set of policy and technology principles for agencies to use as a guide in planning for and using health IT investments that emphasized five principles:
The Markle Common Framework approach, based on Fair Information Practice Principles (FIPPs), has been applied to create two bodies of work. These two frameworks share the same foundational attributes and principles. The variation in the frameworks is how these principles are specifically applied in two different information-sharing contexts as outlined below.
| The Markle Common Framework for Private and Secure Health Information Exchange (released in 2006) | The Markle Common Framework for Networked Personal Health Information (released in 2008) |
|---|---|
| Purpose: Helps health information networks to share information among their members and nationwide while protecting privacy and allowing for local autonomy and innovation. | Purpose: Recommends practices that encourage appropriate handling of personal health information as it flows to and from electronic PHRs and similar applications or supporting services. |
| Focus: Specific to the context of the electronic exchange of patient information among health professionals and health care entities. | Focus: Specific to the context of connecting individuals online to their own information, such as via electronic PHRs, or to other health- related services and applications that use the individual’s personal health information. |
Each of the Policies in Practice and the Policy and Technology Guides of the Markle Common Framework for Private and Secure Health Information Exchange (Markle Common Framework) addresses a subset of relevant core policy and technology principles. The tables in this Appendix identify each resource and its corresponding core policy and technology principles.
Markle Connecting for Health has published a set of policy principles that provide the foundation for privacy and health information technology (IT) in a networked environment. The Markle Connecting for Health approach dictates that these nine principles be balanced together and considered as part of one package. Elevating certain principles over others would weaken any overall architectural solution to privacy protection in a networked health information environment.
In brief, the principles and the corresponding resources are as follows:
In addition to the set of policy principles, Markle Connecting for Health has published a set of technology principles. Together, these principles have guided the specific, practical decisions about the architecture, specifications, and policies that support private and secure sharing of health information across the nation.
In brief, the technology principles and corresponding resources are as follows:
| CORE TECHNOLOGY PRINCIPLES | MARKLE COMMON FRAMEWORK PRACTICE AREAS | POLICIES IN PRACTICE |
|---|---|---|
| 1. Make it “Thin”: Only the minimum number of rules and protocols essential to widespread sharing of health information should be specified as part of a common framework. It is desirable to leave to the local systems those things best handled locally, while specifying at a national level those things required as universal to allow for information sharing among subordinate networks. |
T1: The Common Framework: Technical Issues and Requirements for Implementation T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
Governance of Health Information Sharing Efforts: Achieving Trust and Interoperability with Meaningful Consumer Participation |
| 2. Avoid “Rip and Replace”: Any proposed model for health information sharing must take into account the current structure of the health care system. While some infrastructure may need to evolve, the system should take advantage of what has been deployed today. Similarly, it should build on existing Internet capabilities, using appropriate standards for ensuring secure transfer of information. |
T1: The Common Framework: Technical Issues and Requirements for Implementation T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
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| 3. Separate Applications from the Network: The purpose of the network is to allow authorized persons to access data as needed. The purpose of applications is to display or otherwise use that data once received. The network should be designed to support any and all useful types of applications, and applications should be designed to take data in from the network in standard formats. This allows new applications to be created and existing ones upgraded without re- designing the network itself. |
T1: The Common Framework: Technical Issues and Requirements for Implementation T2: Health Information Exchange: Architecture Implementation Guide T3: Medication History Standards T4: Laboratory Results Standards |
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| 4. Decentralization: Data stay where they are. The decentralized approach leaves clinical data in the control of those providers with a direct relationship with the patient, and leaves judgments about who should and should not see patient data in the hands of the patient and the physicians and institutions that are directly involved with his or her care. |
P1: The Architecture for Privacy in a Networked Health Information Environment P3: Notification and Consent When Using a Record Locator Service T1: The Common Framework: Technical Issues and Requirements for Implementation T2: Health Information Exchange: Architecture Implementation Guide T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
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| 5. Federation: The participating members of a health network must belong to and comply with agreements of a federation. Federation, in this view, is a response to the organizational difficulties presented by the fact of decentralization. Formal federation with clear agreements builds trust that is essential to health information sharing. |
P2: Model Privacy Policies and Procedures for Health Information Exchange P8: Breaches of Confidential Health Information T1: The Common Framework: Technical Issues and Requirements for Implementation T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
Governance of Health Information Sharing Efforts: Achieving Trust and Interoperability with Meaningful Consumer Participation |
| 6. Flexibility: Any hardware or software can be used for health information sharing as long as it conforms to a common framework of essential requirements. The network should support variation and innovation in response to local needs. The network must be able to scale and evolve over time. |
T1: The Common Framework: Technical Issues and Requirements for Implementation T2: Health Information Exchange: Architecture Implementation Guide |
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| 7. Privacy and Security: All health information sharing, including in support of the delivery of care and the conduct of research and public health reporting, must be conducted in an environment of trust; based upon conformance with appropriate requirements for patient privacy, security, confidentiality, integrity, audit, and informed consent. |
P1: The Architecture for Privacy in a Networked Health Information Environment P2: Model Privacy Policies and Procedures for Health Information Exchange P3: Notification and Consent When Using a Record Locator Service P4: Correctly Matching Patients with Their Records P7: Auditing Access to and Use of a Health Information Exchange P8: Breaches of Confidential Health Information P9: A Common Framework for Networked Personal Health Information T1: The Common Framework: Technical Issues and Requirements for Implementation T2: Health Information Exchange: Architecture Implementation Guide T5: Background Issues on Data Quality T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
Individual Access: Connecting Patients with Their Health Information |
| 8. Accuracy: Accuracy in identifying both a patient and his or her records with little tolerance for error is an essential element of health information sharing. There must also be feedback mechanisms to help organizations fix or “clean” their data in the event that errors are discovered. |
P4: Correctly Matching Patients with Their Records P5: Authentication of System Users T1: The Common Framework: Technical Issues and Requirements for Implementation T2: Health Information Exchange: Architecture Implementation Guide T5: Background Issues on Data Quality T6: Record Locator Service: Technical Background from the Massachusetts Prototype Community |
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©2012, Markle Foundation
This work was originally published as part of the Markle Connecting for Health Common Framework Policies in Practice for Health Information Sharing and is made available subject to the terms of a License. You may make copies of this work; however, by copying or exercising any other rights to the work, you accept and agree to be bound by the terms of the License. All copies of this work must reproduce this copyright information and notice.