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US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part IV: Other Potential Applicable Laws

This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

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