it challenges for medical device manufacturers & hospitals
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Simone McCormick, Esq.Murphy Pearson Bradley & Feeney
88 Kearny Street, 10th Floor
San Francisco, CA 94118
(415) 788-1900
IT Challenges for Medical Device Manufacturers &
Hospitals
What are legal implications for Medical Providers and Medical Device Manufacturers based on IEC 80001-1?
Requirements for Medical Providers:
Proper integration of medical devices into medical IT networks
Network Risk Management FileMedical IT Network Risk ManagerTop management accountability for Medical
IT PoliciesTop management’s direct responsibility
regarding residual risk analysis
Legal Issues
Medical malpractice/negligence: Failure to meet the standard of care
Other: HIPAA violations, invasion of privacy, etc.
Medical Device Manufacturers
Full responsibility for Medical/Other Devices in physically isolated network
Accurate specifications re IT characteristics and configuration
Consistent informationSecurity controls for medical devicesContinued assistance
Legal Issues
1) Strict Products Liability (liability without fault)Design defect (potential FDA preemption)Manufacturing defectFailure to warn
2) Other: negligence, fraud, etc.
What is the crucial link between Medical Providers, Medical Device Manufacturers and other Parties such as vendors?
Adequate Responsibility Agreements:
Physical parameters of each medical device: what does manufacturer’s responsibility encompass and where does it end
Task parameters for further consultancy/maintenance by manufacturers or vendors: what does responsibility encompass and where does it end
Notification requirementsLiability/indemnity correlating to the parameters
Regularly update Agreement!
What are Additional IT Challenges?
What Clooney, Roberts and Spears have in common: Data Breaches
Robot vs. Human Care: Overreliance on Automated Devices for Patient Care
Too Much Information: Inferences from Inconsistent Data Collection
Last Words
Have an “open eyes” approach to potential liabilities stemming from the integration of medical devices into IT systems
Carefully design and implement an integration plan
Educate and involve all necessary parties in the integration process
Devise and Update Responsibility Agreements
Thank you!
Simone McCormick, Esq.Murphy Pearson Bradley & Feeney
88 Kearny Street, 10th Floor
San Francisco, CA 94118
(415) 788-1900
IT Challenges for Medical Device Manufacturers &
Hospitals
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