Top 5 Compliance Issues for Medtech Firms Transitioning To Data-enabled Solutions

MedCity News January 27, 2023
Kristin Havranek, Martin Gomez, Matt Wetzel, Steven Tjoe and Stephanie Philbin

Medtech companies should be particularly mindful of the following legal and regulatory compliance issues. This is especially true for companies transitioning to data-based services.

Medtech companies leveraging data must meet FDA and compliance-related requirements, especially given evolving laws and social concerns.

Here are the top 5 compliance issues for medtech-enabled data platforms:

Medtech companies should be particularly mindful of the following legal and regulatory compliance issues:

1. Data Collection, Use and Sharing

Medtech-enabled data platform companies need to be mindful to take appropriate care of data, including:

• • • Patient data
    • Drug development data
    • Customer/provider data
    • AI/ML-developed data sets

Companies should prioritize the following for any data collection, use and sharing:

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