We help manufacturers evaluate healthcare privacy compliance and support their day-to-day healthcare privacy obligations.

Many manufacturers are exposed to patient information every day. Exposure often occurs when reimbursement support is provided, when surgical cases are covered, and when company staff visit customers.

We help companies determine how HIPAA impacts their business and how to protect patient health information in accordance with the Privacy Rule among other requirements.

Contact us to get started.

Contact Us

Representative privacy assignments include:

  • Reviewing for compliance with HIPAA, HITECH, GDPR and CCPA
  • Auditing reimbursement support programs and hubs
  • Responding to requests for manufacturers to sign Business Associate Agreements
  • Reviewing drug and device manufacturer commercial field activities for privacy compliance
  • Helping design privacy-compliant marketing programs
  • Auditing DME makers
  • Counseling manufacturers on the application of the Treatment, Payment and Operations exception
  • Privacy training
  • Case coverage training for field staff
  • Drafting patient authorization and informed consent agreements
  • Counseling manufacturers on how to avoid becoming a Business Associate or Covered Entity
  • Designing, drafting, and implementing privacy policies and procedures
  • Creating remediation plan for breach of patient Protected Health Information (PHI)
  • Assisting manufacturers with matters involving clinical trials and use of patient data
  • Assessing the application of the Privacy Rule in light of conflicting mandated FDA requirements