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

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.

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

10.2196/preprints.24824 ◽

2020 ◽

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

UNSTRUCTURED 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.

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OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocv153 ◽

2015 ◽

Vol 23 (3) ◽

pp. 596-600 ◽

Cited By ~ 18

Author(s):

Taha A Kass-Hout ◽

Zhiheng Xu ◽

Matthew Mohebbi ◽

Hans Nelsen ◽

Adam Baker ◽

...

Keyword(s):

Open Data ◽

The United States ◽

Important Food ◽

The Public ◽

New Public ◽

Application Programming ◽

Public Datasets ◽

Programming Interfaces ◽

Apparent Association

Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Materials and Methods Using cutting-edge technologies deployed on FDA’s new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Results Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products.

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Jazz Works

The Oxford Handbook of Music and Advertising ◽

10.1093/oxfordhb/9780190691240.013.8 ◽

2021 ◽

pp. 162-184

Author(s):

Mark Laver

Keyword(s):

United States ◽

Social Networks ◽

21St Century ◽

Film Music ◽

The United States ◽

Business Practices ◽

Musical Work ◽

Music Business ◽

Government Regulations ◽

The Relationship

In the 21st century, it is widely understood that, to make a living in jazz, Canadian musicians must either take a day job or seek out commercial opportunities in the United States. But it wasn’t always so. Until 1980, Toronto was home to a thriving music industry, driven in large part by a vibrant advertising and film music business. Indeed, far from leaving Canada for greener pastures to the south, musicians (including some Americans) were moving to Toronto. As U.S.-born musician Tom Szczesniak noted, “The streets were paved with gold.” This story complicates broadly accepted jazz discourses in a number of ways. Since it is based in Toronto rather than canonical U.S. jazz centers, it asks readers to re-examine common assumptions about North American jazz geography. As it reveals the relationship between jingles and jazz to be essentially symbiotic (at least for a time), it forces readers to rethink the presumed antagonism between jazz and commerce. Finally, as the story moves into the 1980s, it offers a vivid glimpse into the profoundly deleterious impact of neoliberal business practices and government regulations on social networks among musicians (including the union), and the musical work that sustains them.

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The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing

Policy Politics & Nursing Practice ◽

10.1177/1527154420947028 ◽

2020 ◽

Vol 21 (4) ◽

pp. 195-201

Author(s):

Margaret Martin

Keyword(s):

21St Century ◽

Digital Health ◽

Public Awareness ◽

Health Technology ◽

The United States ◽

Practice Research ◽

Health Technologies ◽

Ethical Implications ◽

Systems Research ◽

21St Century Cures Act

The 21st Century Cures Act, passed in December 2016 by the United States Congress, is a public law aimed at accelerating the time it takes to get pharmaceutical drugs and medical devices into the market, in addition to shifting connected review processes from randomized controlled trials to real-world efficacy tests. As of December 2019, efforts are underway to introduce a “Cures Act 2.0” bill, with particular attention to the implementation of digital health within health systems. Research on the development of emergent health technologies is nascent; research examining health technology implications of 21st Century Cures Act for the health care workforce is nonexistent. This article fills a crucial gap in public awareness, discussing ethical implications of the 21st Century Cures Act and centering nursing. Nursing is a profession frequently acknowledged as practicing on “the front lines of care” and frequently responsible for the trialing of products in clinical settings. The article summarizes and evaluates key components of the 21st Century Cures Act related to health technology development. Discrete health technologies addressed are (a) breakthrough devices, (b) digital health software, and (c) combination products. It then connects these provisions to ethical considerations for nursing practice, research, and policy. The article concludes by discussing the relevance of emerging digital health technologies to the crafting of a “Cures 2.0” bill, with particular attention to this moment in light of digital care precedents set during the COVID-19 pandemic.

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