Project Charter (Draft Version)

This document expresses the goals and scope of the research data use scenarios that will be developed for the “Patient-Centered Outcomes Research (PCOR) Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework” project.

Project Context

This project will address how health information derived from a wide variety of data sources can be used for PCOR and Comparative Effectiveness Research (CER) consistent with 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) will focus on similar questions in the realm of public health. The two projects will contribute to the development of a legal and ethical framework to guide data use by researchers conducting PCOR and CER.

The first phase of the project will focus on developing research data use cases through intensive collaboration with PCOR researchers, patients, providers, health IT technologists, privacy experts and legal experts.  The second phase of the project will focus on developing a framework that will address the legal and regulatory requirements and ethical principles that govern the use of health information for PCOR and CER.

These two phases will use 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 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 standards.

Framing of PCOR and CER

PCOR is research that incorporates:

1. 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;
2. The enhanced capacity to capture, manage, and analyze data from providers and patients.

The goal of PCOR is to produce research findings that give patients and providers a tailored view of their options and possible benefits and harms associated with a particular course of action, allowing patients and providers to make more informed decisions about patient 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:

1. Develop research data use scenarios that describe how data from providers and patients is captured, managed, and used;
2. 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;
3. Describe how users and systems interact to identify data sharing and system interactions and requirements across the research community;
4. Leverage federal and private sector work in the development of the research data use scenarios; and
5. Analyze various operational elements, technical policy requirements, tasks, activities, and information-sharing necessary to support the PCOR/CER community.

Target Outcomes

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 and other systems that manage individually identifiable health information. The scenarios will leverage the legal, regulatory, and ethical knowledge from 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.

We will focus on:

• Identifying research data use scenarios that are patient-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 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, 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 others raised by the group.

Out-of-Scope

This initiative will not include data use scenarios focused on provider or payer operations, nor on educational records. This project will not attempt to address the issues of “data ownership,” but rather will focus on enabling data use for advanced research. We will not be identifying or developing solutions, technical or otherwise—this will be the work of other planned and future initiatives.

Examples of Possible Topics for the Scenarios

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 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 beginning with the kickoff meeting on December 1, 2015. During an intensive process, we will develop draft scenarios to be submitted to the client in February 2016. Following feedback from ONC, we will submit the final scenarios in April 2016. In August 2016, the scenarios will be circulated for comment among the larger research community and will be finalized and submitted to ONC in October 2016.