Artificial Intelligence (AI) and Machine Learning (ML) algorithms have been integrated into FDA-approved medical devices and are starting to be used in clinical care. The laws that govern this rapidly innovative field are often playing catchup: for example, the 21st Century Cures Act of 2016 made several statutory changes in an attempt to define the scope of FDA's regulatory authority over software (including AI). Specifically, it carved out 5 functions or uses of software that would be exempted from review as a medical device: administrative support, healthy lifestyle/wellness, electronic patient records, transfer/storage of medical device data, and clinical support. The last category, termed Clinical Decision Support Software (CDS) was further interpreted by the FDA in a Sept. 2022 Guidance that seemed to narrow the exemption, bringing many devices that use software to guide clinical decisions within the purview of FDA review
This is pertinent to medical malpractice and products liability law because some devices that are approved by the FDA are exempted from torts liability should the device eventually cause any patient harm via the doctrine of federal preemption. The practitioners who use those devices, however, are not similarly immunized. Jurisprudentially, these laws attempt to apportion liability based on the relative degree of culpability: if the practitioner caused the harm, they should be held liable; if the device/manufacturer caused the harm, it should be held liable. However, such bright lines will be difficult to draw for AI-integrated medical devices due to the intricate interplay between software, device, and practitioner. Moreover, crafting these legal proposals will require an in-depth understanding of multiple areas of the law (especially considering that some of the bellwether litigation for these devices will be seen in the lawsuits against Tesla and other autonomous vehicles).
We are seeking a Research Assistant who will research and summarize statutes and case law in the areas of medical device product liability, autonomous vehicle product liability, and medical malpractice laws regarding the use of AI/ML devices as well as drafting and editing manuscripts.
Specific duties & responsibilities
Utilize legal research databases
Independent library and case law research
Written data analysis
Assists in the development of tables and figures for reports and manuscripts
Assists in the maintenance of project databases
Other duties as assigned.
Special knowledge, skills, and abilities
Must be able to prioritize and coordinate multiple tasks. Must have the ability to work well and communicate effectively with others. Must have strong organizational skills, attention to detail, be able to work independently and as part of a team, initiative, strong leadership skills, and an ability to work with a team of researchers and with diverse subject populations. Excellent oral and written communication skills. Working knowledge of PC operations and software applications such as MS Windows, Excel, Word, and Access required. Ability to learn new database and software applications is required. Ability to follow multiple, detailed directions of various protocols. Knowledge of medical terminology highly desired. Must have excellent time management skills.
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Assistant Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: Min $16.75-Max $29.30 HRLY($20,000 budgeted commensurate with experience) Employee group: Casual / On Call Schedule: Varies Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM DOM JHH Hospitalists Personnel area: School of Medicine
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Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
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