Health Equity’s Growing Impact on Regulatory and IP Protection

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ARTICLE SUMMARY:

The issue of health equity is emerging as an important part of the medtech product development process as it is increasingly becoming a component of regulatory and legal review, including intellectual property protection. Companies that ignore this trend do so at their own peril as the level of awareness continues to grow worldwide.

Health equity is viewed by many as an issue that largely affects our healthcare system as a whole in terms of ensuring how care and services are delivered fairly across the entire population without regard to income, gender, race, ethnicity, or other factors that may otherwise restrict access to care as part of the larger diversity and inclusion (D&I) and environmental, social, and governance (ESG) debate. While that is where the health equity debate started, it has quickly spread across all aspects of the healthcare system, including the product development process—most notably into regulatory and legal elements, such as intellectual property (IP) protection. The consideration of health equity concerns, in the broadest sense, varies across the spectrum of regulatory and policy considerations—the issues facing FDA are different than those for the US Patent and Trademark Office (USPTO), but it has clearly become an important part of the ongoing debate on all aspects of medtech product development.

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