IT Challenges for Medical Device Manufacturers & Hospitals - PowerPoint PPT Presentation

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IT Challenges for Medical Device Manufacturers & Hospitals PowerPoint Presentation
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IT Challenges for Medical Device Manufacturers & Hospitals
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IT Challenges for Medical Device Manufacturers & Hospitals

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  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