Presentation is loading. Please wait.

Presentation is loading. Please wait.

Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA 94118 (415) 788-1900 IT Challenges for Medical Device.

Similar presentations


Presentation on theme: "Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA 94118 (415) 788-1900 IT Challenges for Medical Device."— Presentation transcript:

1 Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA (415) IT Challenges for Medical Device Manufacturers & Hospitals

2 What are legal implications for Medical Providers and Medical Device Manufacturers based on IEC ?

3 Requirements for Medical Providers: Proper integration of medical devices into medical IT networks Network Risk Management File Medical IT Network Risk Manager Top management accountability for Medical IT Policies Top management’s direct responsibility regarding residual risk analysis

4 Legal Issues Medical malpractice/negligence: Failure to meet the standard of care Other: HIPAA violations, invasion of privacy, etc.

5 Medical Device Manufacturers Full responsibility for Medical/Other Devices in physically isolated network Accurate specifications re IT characteristics and configuration Consistent information Security controls for medical devices Continued assistance

6 Legal Issues 1) Strict Products Liability (liability without fault) Design defect (potential FDA preemption) Manufacturing defect Failure to warn 2) Other: negligence, fraud, etc.

7 What is the crucial link between Medical Providers, Medical Device Manufacturers and other Parties such as vendors?

8 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 requirements Liability/indemnity correlating to the parameters Regularly update Agreement!

9 What are Additional IT Challenges?

10 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

11 Last Words

12 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!

13 Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA (415) IT Challenges for Medical Device Manufacturers & Hospitals


Download ppt "Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA 94118 (415) 788-1900 IT Challenges for Medical Device."

Similar presentations


Ads by Google