Law School Citations

Law school journals published by Southern Methodist University (Dedman School of Law), the University of Michigan and the University of California (Davis) have all included papers referencing work that was created by Ken Block Consulting (KBC), such as website content or published articles. KBC authored content has also been used as part of Harvard University coursework on cybersecurity, plus referenced in publications by other educational organizations. Given our strong capabilities and knowledge in the regulated medical device industry, KBC serves as an expert source of content for academic writers on topics including digital health, FDA regulatory pathways, usability and FDA regulations for mobile apps.

Fertile Ground: Rethinking Regulatory Standards for Femtech, Alexandra M. Taylor, UC (University of California) Davis Law Review, Volume 54

https://lawreview.law.ucdavis.edu/issues/54/4/note/files/54-4_Taylor.pdf

 

Natural Cycles: When an Algorithm Digitally Mandates Your Sexual Health, Jacqueline Tran, Southern Methodist University, Dedman School of Law, Science and Technology Law Review, Volume 22

https://scholar.smu.edu/cgi/viewcontent.cgi?article=1292&context=scitech

 

Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program, Stephen McInerney, University of Michigan Journal of Law Reform, Volume 48

https://repository.law.umich.edu/cgi/viewcontent.cgi?article=1143&context=mjlr

 

The Cyber World: Governance, Threats, Conflict, Privacy, Identity, and Commerce, Lecture 9: Usability, Accessibility, What are the FDA Usability Testing Requirements for Device Approval? [Published in EMDT, Author: Kenneth L. Block]

https://wiki.harvard.edu/confluence/display/csci45/Spring+News+You+Can+Use

 

Digital Therapeutics: Why is it and Why Does it Matter, Douglas L. Gourlay, Taurus Medical Education

https://cme.tarsusmedicaleducation.com/sites/default/files/KEY-06%20-%20Digital%20Therapeutics%20%28Gourlay%29.pdf

 

Cuffed Pediatric Endotracheal Tubes, Jennifer Nutter, et al., Honors Theses, Biomedical Devices and Instrumentation Commons, Union College

https://digitalworks.union.edu/cgi/viewcontent.cgi?article=3327&context=theses