Off-Label Marketing's Audiences: The 21st Century Cures Act and the Relaxation of Standards for Evidence-Based Therapeutic and Cost-Comparative Claims

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.

Download Full-text

US 21st Century Cures Act secures health-care research funding

The Lancet Oncology ◽

10.1016/s1470-2045(16)30636-2 ◽

2017 ◽

Vol 18 (1) ◽

pp. 24 ◽

Cited By ~ 1

Author(s):

Bryant Furlow

Keyword(s):

Health Care ◽

21St Century ◽

Research Funding ◽

Health Care Research ◽

Care Research ◽

21St Century Cures Act

Download Full-text

The 21st Century Cures Act and the Future of Health Education and Health-Related Behavioral Research

Health Education & Behavior ◽

10.1177/1090198117709044 ◽

2017 ◽

Vol 44 (3) ◽

pp. 353-355

Author(s):

William C. Livingood ◽

John P. Allegrante

Keyword(s):

Health Education ◽

21St Century ◽

Behavioral Research ◽

Education And Health ◽

The Future ◽

Health Related ◽

21St Century Cures Act

Download Full-text

21st Century Cures Act

Hospital Pharmacy ◽

10.1310/hpx5204-264 ◽

2017 ◽

Vol 52 (4) ◽

pp. 264-265 ◽

Cited By ~ 12

Author(s):

Michael Gabay

Keyword(s):

21St Century ◽

21St Century Cures Act

Download Full-text

The 21st Century Cures Act: A Competitive Apps Market and the Risk of Innovation Blocking

Journal of Medical Internet Research ◽

10.2196/24824 ◽

2020 ◽

Vol 22 (12) ◽

pp. e24824

Author(s):

William J Gordon ◽

Kenneth D Mandl

Keyword(s):

21St Century ◽

Health Care Organizations ◽

The United States ◽

Business Practices ◽

Hospital System ◽

Final Rule ◽

Application Programming ◽

Innovation Blocking ◽

Programming Interfaces ◽

21St Century Cures Act

The 21st Century Cures Act and the recently published “final rule” define standardized methods for obtaining electronic copies of electronic health record (EHR) data through application programming interfaces. The rule is meant to create an ecosystem of reusable, substitutable apps that can be built once but run at any hospital system “without special effort.” Yet, despite numerous provisions around information blocking in the final rule, there is concern that the business practices that govern EHR vendors and health care organizations in the United States could still stifle innovation. We describe potential app ecosystems that may form. We caution that misaligned incentives may result in anticompetitive behavior and purposefully limited functionality. Closed proprietary ecosystems may result, limiting the value derived from interoperability. The 21st Century Cures Act and final rule are an exciting step in the direction of improved interoperability. However, realizing the vision of a truly interoperable app ecosystem is not predetermined.

Download Full-text

HARNESSING HEURISTICS FOR ECONOMIC POLICY

Economics and Philosophy ◽

10.1017/s026626711700030x ◽

2018 ◽

Vol 34 (2) ◽

pp. 135-163

Author(s):

Ramzi Mabsout ◽

Jana G. Mourad

Keyword(s):

Economic Policy ◽

21St Century ◽

Decision Makers ◽

Policy Implications ◽

Evidence Based ◽

Fast And Frugal Heuristics ◽

Changing Environments ◽

Effective Decision ◽

Biases And Heuristics ◽

Behavioural Sciences

Abstract:The effectiveness of heuristics has received contradicting interpretations in the behavioural sciences. We study the policy implications of two programmes that dispute the effectiveness of heuristics – the biases and heuristics and the fast and frugal heuristics programmes. While the first blames heuristics for most errors in judgement, the second posits heuristics as simple mental algorithms that work well in a range of environments. We argue that the fast and frugal programme is less paternalistic insofar as it models humans as effective decision-makers in a range of environments. However, in the rapidly changing environments of the 21st century, both are needed to inform evidence-based policies.

Download Full-text