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This project will address how health information derived from a wide variety of data sources can be used for patient-centered outcomes research (PCOR and Comparative Effectiveness Research ) and comparative effectiveness research (CER), consistent with ethical principles of ethics and legal and regulatory requirements related to patient consent, privacy, and autonomy. A companion project of the Centers for Disease Control and Prevention (CDC) companion project will focus on similar questions in the realm of public health . The two projects realm. This and the CDC project will contribute to the development of a legal and ethical framework to that will guide data use by researchers conducting PCOR and CER.
The first project phase of the project will focus on developing research data use cases scenarios through intensive collaboration with PCOR researchers, patients, providers, health IT technologists, privacy experts, and legal experts. The The second project phase of the project will focus on developing a framework that will address addresses the legal and regulatory requirements and ethical principles that govern governing the use of health information for PCOR and CER.
These The two phases will use both utilize a shared online project collaboration space, webinars, WebEx(s), and use case documents so that the work of each phase will inform the other. The project’s objective of the project is to create a practical, technology-neutral legal and ethical framework that makes sense to researchers, patients, and providers , and that can guide health IT developers and policy makers to responsibly use and protect data for PCOR and CER.
Finally, the research data use scenarios and the legal and ethical framework developed through this project will be used by a related ONC project tasked with layering a technical framework onto our legal and ethical framework and developing related technical standardsidentifying or developing technical standards for capturing patient choice, including basic choice for treatment, basic choice for research, and granular choice.
Framing of PCOR and CER
PCOR is research that incorporates:
- Advanced approaches to assessing provider and patient preferences, health-related quality of life (HRQoL), clinical efficacy, potential side effects of treatment and drug therapies, and the impact of patient genetic predisposition , and;
- The enhanced capacity to capture, manage, and analyze data from providers and patients.
The PCOR’s goal of PCOR is to produce research findings that give patients and providers a an individually tailored view of their treatment options and the possible benefits and harms associated with a particular course of action, allowing patients and providers the patient and provider(s) to make more informed decisions about patient the patient’s health and healthcare.
CER is defined as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels."[1]
Goals
The main goals for this project are to:
- Develop research data use scenarios that describe how data from providers and patients is captured, managed, and used;
- Ensure that the research data use scenarios address key issues that researchers face, are representative of practical industry-wide needs, and are valuable for solving real-world PCOR/CER challenges;
- Describe how users and systems interact to identify data-sharing and system interactions and requirements across the research community;
- Leverage federal and private sector work in developing the development of the research data use scenarios; and
- Analyze various operational elements, technical policy requirements, tasks, activities, and information-sharing necessary to support the PCOR/CER community.
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We will convene a group of PCOR/CER stakeholders and facilitate an interactive process to develop 15-20 priority research data use scenarios. These scenarios will describe user actions, system interactions, and information-sharing requirements for PCOR and CER. In developing the research data use scenarios, the NORC team will draw upon federal and private sector work focused around privacy and security for PCOR/CER, and engage with a broad range of stakeholders , including: patients, patient advocates, providers, payers, researchers, health IT vendors, standards organizations, public health organizations, and federal agencies.
A range of scenarios will be constructed and then examined to determine the different ways PCOR and CER researchers might interact with Electronic Health Records (EHR) systems electronic health records (EHRs) and other systems that manage individually identifiable health information. The scenarios will leverage inform the legal, regulatory, and ethical knowledge from framework developed during Phase 2 (PCOR Legal Analysis and Ethics Framework), as well as the research that takes place in Phase 2.
In-Scope
Our task is to identify the policy, legal, and ethical components and requirements to support data use in PCOR and CER while protecting patient privacy.
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- Identifying research data use scenarios that are patientperson-centric and encompass PCOR and CER;
- Identifying necessary policies and requirements to enable data use in research;
- Defining the gaps and needs in policies and ethical and legal requirements; and
- Identifying instances where technical components intersect with policy requirements, referencing relevant technical specifications as needed
In addition to clinical and administrative data, other data types of interest would include: patient-generated health data, ; genomic data, ; bio-specimens, ; behavioral health data, ; survey , data; social determinants of health, ; and data from special populations of interest, including under-represented and culturally diverse populations.
We may consider issues related to: data characteristics (identifiability, type, source), ; data handling (storage, transmission, collection), ; data uses (purpose, scope of consent), ; the users and facilities interacting with the data (collector, data user, location of collection and use), as well as ; and others raised by the multi-stakeholder group.
Out-of-Scope
This initiative will not include data use scenarios focused on provider or payer operations , nor or on educational records. This project will not attempt to address the data “ownership” issues of “data ownership,” but rather will focus , focusing instead on enabling data use for advanced research. We will not be identifying identify or developing develop solutions , (technical or otherwise—this otherwise); this will be the work of other planned and future initiatives.
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The stakeholder group will work together to brainstorm topics for the research data use scenarios and then to fully describe and develop those scenarios and their specifications. Some possible areas of interest include, but are not limited to:
- Collection Data collection and sharing of data with potential use for research purposes;
- Merging of large databases for research purposes;
- Research related to precision medicine;
- Research/information-sharing within and across multiple entities/institutions;
- Laboratory data for research purposes;
- Patient-generated data used for research purposes; and
- Familial/community implications of research data collection and use.
Timeline
The research data use scenarios will be developed through a collaboration with stakeholders the multi-stakeholder group beginning with the kickoff meeting on December 1, 2015. During an intensive process with the group, we will develop draft scenarios to be submitted to the client and submit them to ONC in February 2016. Following feedback from ONCAfter obtaining ONC’s feedback on these draft scenarios, we will submit the final revised scenarios to ONC in April 2016. In After a period of discussion and revisions, in August 2016, we will circulate the scenarios will be circulated for comment among revised scenarios across the larger research community and for comment. The scenarios will be finalized and submitted to ONC in October 2016.
