Medical device manufacturers, pharmaceutical companies, and contract manufacturers producing health-related products encounter HIPAA obligations when their devices collect, store, or transmit Protected Health Information. Connected medical devices, remote patient monitoring systems, and companion apps create direct data relationships with patients that make manufacturers business associates under HIPAA. As healthcare moves toward connected, data-driven devices, HIPAA compliance becomes a product requirement, not just an organizational one.
4-8 months for manufacturing HIPAA program covering device and enterprise systems
$25,000-$75,000 for medical device manufacturer HIPAA program with device security controls
PoliWriter generates all the policies you need for HIPAA compliance, customized to your manufacturing tech stack and practices. Hours, not months.
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