Featured in Med Device Online: Contracts Every Wearable Company Needs

Our article on the legal foundations every wearable medical device company needs was recently selected as a featured editorial by Med Device Online. The piece explores how companies in this space can use contracting strategy to navigate regulatory complexity and minimize legal exposure.

Read the article:

Wearable Medical Devices – What Should Your Contracts Look Like?

The article outlines essential components of a strong contracting framework, including:

• Business associate responsibilities under HIPAA
• Business associate agreements (BAAs)
• Service agreements with healthcare providers
• Website and portal terms
• Regulatory and enforcement risks spanning HIPAA, the FTC and state law

It also offers practical insights for building a legally sound foundation:

• Know your regulatory category: HIPAA, state laws and FTC rules determine your baseline obligations
• Build in HIPAA from the start: If your wearable handles PHI as a business associate, your tech stack and contracts must meet HIPAA standards, including BAAs with providers and vendors
• Strengthen your contracts: Use BAAs, provider agreements, and clickwrap terms ensure compliance and help allocate risk
• Tighten privacy practices: Align website terms and privacy policies with FTC and state laws
• Use PHI cautiously with AI: Training or analytics may require authorization or full de-identification
• Expect multi-agency oversight and enforcement: A single incident may draw scrutiny from FDA, OCR, FTC, SEC, state attorneys general and class action lawsuits

Many thanks to Med Device Online for featuring our work.