Medical Device HIPAA Compliance Toolkit

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. 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.

Questionnaire

Take the questionnaire to personalize your document library.

Medical device manufacturers are covered by HIPAA in limited circumstances. This questionnaire will help assess the extent to which HIPAA applies to your company.

Key contacts

Email us

Marcy Wilder

Washington, D.C.

Partner

Paul Otto

Washington, D.C.

Partner

Melissa Levine

Washington, D.C.

Counsel

* The results of this survey are based on the responses provided. We have not independently verified the results. The documents provided are templates and intended to be used as a starting point for developing a HIPAA compliance program, as applicable, or for use where HIPAA does not apply. They should be customized for your company, activities and processes. There may be other HIPAA or general privacy compliance documentation that your company may need, depending on your company’s activities and the laws that apply to it. To the extent you want any assistance with confirming the results of the survey, customizing the relevant documents, or assessing whether further compliance documentation is necessary, please contact the Hogan Lovells privacy team.