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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 

Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/

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.

**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Accommodation Information

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Note: Job Postings are updated daily and remain online until filled.

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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