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