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Medical Device HIPAA Compliance Toolkit

We simplify HIPAA compliance and provide documentation to help your company implement a HIPAA compliance program

Medical device companies can be subject to HIPAA if they conduct certain electronic transactions or if they engage in certain activities or functions involving protected health information. Determining whether and how HIPAA applies can be challenging, but we simplify this process.

Our compliance toolkit questionnaire will help you assess the extent to which HIPAA applies to your company and then, based on your responses to the questionnaire, we provide a set of policies and other documentation to help your company establish a HIPAA compliance program.

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  • Does HIPAA apply to your medical device company?
  • If so, how does HIPAA apply and what do you need to do to implement a HIPAA compliance program?
  • How do you conduct a Risk Analysis as required by the HIPAA Security Rule?
  • What policies should you have in place to help you assess that your uses and disclosures of Protected Health Information (PHI) comply with HIPAA?
  • What are the key documents you need to comply with HIPAA privacy, security, and breach notification obligations?
  • Our questionnaire will help you assess the extent to which HIPAA applies to your company and then create a personalized library of the key documents to help you establish a HIPAA compliance program.
  • These documents have been standardized for ease of reference, and also contain key drafting notes to help you tailor and customize the documents and policies to your company’s processes and activities.
  • Included in the subscription price is a support package giving you direct access to top lawyers on our team for questions or support.
  • Our team of privacy and cybersecurity lawyers regularly update the HIPAA document templates in response to any significant changes in the law or regulatory guidance.

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