Cybersecurity, Privacy and Security Guidance for Medical Device Manufacturers

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Cybersecurity, Privacy and Security Guidance for Medical Device Manufacturers

With electronic medical devices capable of logging and storing more and more data on device use and patient health, cybersecurity risks from medical devices are growing. Even the FBI recently warned the industry that this will create a rich environment for cybercriminals to exploit.

Cyberattacks on medical devices can compromise not only the safety of patients, but also the security of hospitals and healthcare networks. Electronic protected health information is enormously valuable to cyberthieves, who can use stolen data for insurance fraud, identity theft and other crimes. But perhaps most importantly, the potential harmful threat to patients is all too real.

What can you do now to prepare? Order Cybersecurity, Privacy and Security Guidance for Medical Device Manufacturers from FDAnews. It'll give you what you need to deal with cybersecurity risks and HIPAA/HITECH compliance, including:

  • How to develop effective cybersecurity measures given the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information
  • The technology standards and best practices that come into play for devicemakers under HIPAA/HITECH, including organizational requirements and administrative, physical and technical safeguards
  • The 10 key elements you need in your business agreements to give business associates legal access to PHI (protected health information)
  • How to deal with the FDA's approach to cybersecurity of medical devices, including risk analysis, safety alerts and patches and updates to software used in devices
  • And much, much mor

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Table of Contents

  • Cybersecurity Concerns
  • HIPAA/HITECH Compliance
  • Exemptions and Exclusions

View the entire TOC

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This report is largely based on information provided during an FDAnews webinar by Seth A. Mailhot, partner and lead in the FDA regulatory practice with Michael Best and Friedrich, LLP, in Washington, D.C.

Mr. Mailhot has worked on FDA-related matters for more than 20 years, starting with a technical and enforcement position at the FDA. Since entering private practice, he counsels clients on FDA regulation, as well as related matters regulated by the U.S. Department of Agriculture and HHS.

  • Device company executives
  • Device company subcontractors
  • Risk managers
  • IT systems managers
  • IT security managers
  • Software developers
  • Device app developers
  • Regulatory affairs officers
  • Device vendors

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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