FDA and the Marketplace of Ideas for Medical Products

2017 ◽  
Vol 45 (S2) ◽  
pp. 39-41
Author(s):  
Nathan Cortez
Keyword(s):  
21St Century ◽  
Working Group ◽  
Marketplace Of Ideas ◽  
Misleading Information ◽  
Medical Products ◽  
Statutory Authority ◽  
Fda Approval ◽  
21St Century Cures Act ◽  
Do So

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.

scholarly journals A proposal for shoring up Federal Trade Commission protections for electronic health record–connected consumer apps under 21st Century Cures

2020 ◽  
Author(s):  
Raheel Sayeed ◽  
James Jones ◽  
Daniel Gottlieb ◽  
Joshua C Mandel ◽  
Kenneth D Mandl
Keyword(s):  
Information Technology ◽  
Health Insurance ◽  
21St Century ◽  
Medical Records ◽  
Federal Trade Commission ◽  
Health Data ◽  
Health Record ◽  
Statutory Authority ◽  
Patient’S Rights ◽  
21St Century Cures Act

Abstract Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient’s rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act–covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps. A technologically feasible workflow that could be widely adopted and permissible under ONC’s rule, involves using the SMART on FHIR OAuth authorization routine to present standardized information about app behavior. This approach would not bias the patient in a way that triggers penalties under information blocking provisions of the rule.

scholarly journals Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020

2021 ◽  
Vol 19 (4) ◽  
pp. 378-384
Author(s):  
Leigh Gallo ◽  
Ronald S. Walters ◽  
Jeff Allen ◽  
Jenny Ahlstrom ◽  
Clay Alspach ◽  
...  
Keyword(s):  
21St Century ◽  
Cancer Care ◽  
Working Group ◽  
Policy Recommendations ◽  
Patient Access ◽  
Care Research ◽  
Access To Data ◽  
Research Initiatives ◽  
21St Century Cures Act ◽  
Funding Research

The 21st Century Cures Act (Cures Act), signed into law in 2016, was designed to advance new therapies by modernizing clinical trials, funding research initiatives, and accelerating the development and use of health information technology. To analyze the current issues in cancer care related to the implementation and impact of the Cures Act, NCCN convened a multistakeholder working group. Participants discussed the legislation’s impact on the oncology community since enactment and identified the remaining gaps and challenges as experienced by stakeholders. In June 2020, the policy recommendations of the working group were presented at the virtual NCCN Policy Summit: Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020. The summit consisted of informative discussions and a multistakeholder panel to explore the recommendations and the future of the Cures Act. This article explores identified policy recommendations from the NCCN Working Group and the NCCN Policy Summit, and analyzes opportunities to advance innovative cancer care and patient access to data.

NASPAG/SAHM Statement: The 21st Century Cures Act and Adolescent Confidentiality

2021 ◽  
Vol 68 (2) ◽  
pp. 426-428
Author(s):  
Jennifer Carlson ◽  
Rachel Goldstein ◽  
Kim Hoover ◽  
Nichole Tyson
Keyword(s):  
21St Century ◽  
21St Century Cures Act

Modernization in GUM/HIV services: what does it mean?

2003 ◽  
Vol 14 (2) ◽  
pp. 89-98 ◽  
Author(s):  
Angela J Robinson ◽  
Karen Rogstad
Keyword(s):  
Quality Of Service ◽  
Sexually Transmitted Infections ◽  
21St Century ◽  
Working Group ◽  
Local Population ◽  
Hiv Services ◽  
Sexually Transmitted ◽  
Measuring Outcomes ◽  
Genitourinary Medicine

Genitourinary medicine services are expected to modernize in order to meet the needs of the NHS in the 21st century. Although increased funding is essential, there is a need for services to look at new ways of delivering care in order to deal with the increasing rate of sexually transmitted infections (STIs) including HIV in the community. This must include a review of skill-mix and roles. Some changes may appear to lower the quality of service. There must be auditing of changes to ensure that standards are not lowered. A short-lived working group was put together at the request of the RCP joint speciality committee for GUM consisting of representatives from diverse GUM clinics which have all been involved in extensive modernization of their service in order to meet demand. This report does not hold all the answers but provides suggestions for clinics wishing to initiate change. Changes must be appropriate to the local population and access pressures. More extreme measures may only be appropriate in the most severely stretched clinics and with consideration of measuring outcomes.

The End of the HIPAA Privacy Rule?

2016 ◽  
Vol 44 (2) ◽  
pp. 352-358 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
21St Century ◽  
Regulatory Action ◽  
Common Rule ◽  
Privacy Rule ◽  
Federal Research ◽  
Incomplete Coverage ◽  
Research Regulations ◽  
Hipaa Privacy Rule ◽  
21St Century Cures Act

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.

The Norm Orientation of English in the Caribbean

2021 ◽  
pp. 1-40
Author(s):  
Dagmar Deuber ◽  
Stephanie Hackert ◽  
Eva Canan Hänsel ◽  
Alexander Laube ◽  
Mahyar Hejrani ◽  
...  
Keyword(s):  
21St Century ◽  
American English ◽  
Media Exposure ◽  
Quantitative Investigation ◽  
British English ◽  
Mass Tourism ◽  
The Caribbean ◽  
Newspaper Writing ◽  
British Colonies ◽  
Do So

This study examines newspaper writing from ten Caribbean countries as a window on the norm orientation of English in the region. English in the former British colonies of the Caribbean has been assumed to be especially prone to postcolonial linguistic Americanization, on account of not just recent global phenomena such as mass tourism and media exposure but also long-standing personal and sociocultural links. We present a quantitative investigation of variable features comparing our Caribbean results not just to American and British reference corpora but also to newspaper collections from India and Nigeria as representatives of non-Caribbean New Englishes. The amount of American features employed varies by type of feature and country. In all Caribbean corpora, they are more prevalent in the lexicon than in spelling. With regard to grammar, an orientation toward a singular norm cannot be deduced from the data. While Caribbean journalists do partake in worldwide American-led changes such as colloquialization, as evident in the occurrence of contractions or the tendency to prefer that over which, the frequencies with which they do so align neither with American English nor with British English but often resemble those found in the Indian and Nigerian corpora. Contemporary Caribbean newspaper writing, thus, neither follows traditional British norms, nor is it characterized by massive linguistic Americanization; rather, there appears to be a certain conservatism common to New Englishes generally. We discuss these results in light of new considerations on normativity in English in the 21st century.

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