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Public Policy Issues in Clinical Research Informatics

  • Jeffery R. L. SmithEmail author
Chapter
Part of the Health Informatics book series (HI)

Abstract

Recently, a national imperative to “develop better cures faster” has been a rally cry for clinical research, as stakeholders work to apply advances in data storage, computation, and methodology toward the clinical research enterprise. This work is, at its core, the domain of Clinical Research Informatics (CRI), and the intersection of public policy and CRI will be the focus of this chapter. The goal of this chapter is to provide a foundation for clinical research policies impacting the domain of CRI and to describe the emerging landscape of public policies likely to impact CRI for some time to come.

Keywords

Public policy Common Rule Regulatory science Compliance Privacy Consent Data sharing HIPAA 

Acronyms

AHRQ

Agency for Healthcare Research and Quality

All of Us

NIH All of Us Research Program

AMIA

American Medical Informatics Association

CDC

Centers for Disease Control and Prevention

CDRH

FDA Center for Devices and Radiological Health

CFR

Code of Federal Regulations

Common Rule

Federal Policy for the Protection of Human Subjects (45 CFR Part 46)

FD&C Act

Food, Drug, and Cosmetic Act of 1938

FDA

Food and Drug Administration

HeLa

Immortalized cell line of Henrietta Lacks

HIPAA

Health Insurance Portability and Accountability Act of 1996

IRB

Investigational Review Board

MDUFA

Medical Device User Fee Act

MIDD

Model-informed drug development

NIH

National Institutes of Health

NLM

National Library of Medicine

NPRM

Notice of proposed rulemaking

OIRA

Office of Information and Regulatory Affairs

OMB

White House Office of Management and Budget

ONC

Office of the National Coordinator for Health Information Technology

PCORI

Patient-Centered Outcomes Research Institute

PDUFA

Prescription Drug User Fee Act

PHI

Protected health information

PHSA

Public Health Services Act of 1944

PMI

Precision Medicine Initiative

PPACA

Patient Protection and Affordable Care Act of 2010

PreCert

FDA software precertification pilot program

RWD

Real-world data

RWE

Real-world evidence

SaMD

Software-as-a-Medical Device

SIMD

Software-inside-a-Medical Device

Copyright information

© Springer International Publishing 2019

Authors and Affiliations

  1. 1.American Medical Informatics AssociationBethesdaUSA

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