HIPAA-HITECH Compliance Strategies for Medical Device Manufacturers

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers - Webinar CD/Transcript

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Today's medical devices can store extensive personal health information and easily share it with others.

That’s a good thing sometimes, but it also opens up medical device manufacturers to significant compliance challenges from both HIPAA and the HITECH Act.

If your product is involved in a data breach involving disclosure of protected health information (PHI), HHS could fine you as much as $1.5 million.

This webinar cd and transcript set helps you determine if your product stores PHI, could you be unwittingly in a Business Associate relationship with customers and how best to structure your contracts to avoid liability, fines and penalties.

To start, you must understand specifically how and when HIPAA and HITECH apply to your company … before you can even begin to assess your culpability in the event of a data breach.

As a devicemaker, you’ve heard of HIPAA and may have thought it didn’t apply to you. On January 17, HHS released the much-anticipated HIPAA final rule. The expanded rule makes business associates of covered entities (and their subcontractors) directly liable for compliance with the HIPAA security rules and certain parts of the HIPAA privacy rules. More than ever, you need to clearly understand if you’re responsible for HIPAA/HITECH compliance.

All of these regulations —and recent changes to them — have significant implications for you and your company, specifically in the importance of implementing sufficient security and privacy protocols to avoid data breaches that can lead to fines and penalties.

This FDAnews webinar cd and transcript set provides you with what you need to understand the complexities of these overlapping regulations. You'll get the answers you need to these questions:

  • When does medical device-related information qualify as Protected Health Information?
  • What are the differences between HIPAA's Privacy Rule and Security Rule?
  • When do Business Associate relationships exist with a Covered Entity? (It's more complicated than you think.)
  • What procedures, processes or protections do you need to include in your agreements with Business Associates in case of a data breach?
  • Could your concerns about cybersecurity and cloud computing increase HIPAA/HITECH non-compliance?
  • And more

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers is designed especially to provide the tools you need to better understand how HIPAA, HITECH and the HIPAA "final rule" impact on you and your business. With significant fines and penalties possible, don't take chances.

  • Legal affairs
  • Regulatory affairs
  • Software development directors
  • IT security and systems
  • Risk management directors
  • Contracting and commercial development directors

Seth Mailhot leads the FDA Regulatory practice at Michael Best & Friedrich LLP, and is a member of the firm’s Transactional Practice Group in the Washington, D.C., office. Mr. Mailhot has worked on FDA-related matters for more than 20 years, starting in various technical and enforcement positions at the FDA. Since entering private practice, Mr. Mailhot counsels clients on all aspects of regulation by FDA, as well as related matters regulated by USDA and HHS, such as the requirements of the National Organic Program, compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Health Information Technology for Economic and Clinical Health Act (HITECH).