1 / 13

IT Challenges for Medical Device Manufacturers & Hospitals

IT Challenges for Medical Device Manufacturers & Hospitals. Simone McCormick, Esq. Murphy Pearson Bradley & Feeney 88 Kearny Street, 10 th Floor San Francisco, CA 94118 (415) 788-1900. What are legal implications for Medical Providers and Medical Device Manufacturers based on IEC 80001-1?.

shelly
Download Presentation

IT Challenges for Medical Device Manufacturers & Hospitals

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

  2. What are legal implications for Medical Providers and Medical Device Manufacturers based on IEC 80001-1?

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

More Related