HHS’s legislative agenda over the next 6-12 months and the opportunities for healthcare product leaders

The regulatory agenda from the U.S. Department of Health and Human Services (HHS) outlines key priorities for the healthcare sector. Here is HHS’s legislative agenda over the next 6-12 months and the opportunities for healthcare product leaders in this space:

Understanding HHS’s Regulatory Agenda

The Department of Health and Human Services (HHS) serves as the federal government’s primary entity for promoting public health and advancing the development of healthcare products and services. HHS’s regulatory agenda provides crucial insights into forthcoming changes in healthcare policies, payment systems, and compliance standards. These regulations affect stakeholders across the healthcare continuum, including payers, providers, pharmaceutical companies, and medical device manufacturers.

Key HHS Regulatory Proposals

Based on the agenda and priorities laid out, here are the most impactful potential regulatory actions for healthcare product leaders:

1. Nondiscrimination in Health Programs or Activities

HHS intends to expand protections under Section 1557 of the Affordable Care Act, which prohibits discrimination in healthcare based on race, color, national origin, sex, age, or disability. This initiative emphasizes improving access and equity in healthcare systems.

• Implications for Healthcare Product Leaders:

• Vendors developing health IT or patient engagement tools must ensure their platforms comply with accessibility and non-discrimination standards, particularly for individuals with disabilities or limited English proficiency.

• Diversity and inclusivity must be prioritized in clinical trials and product design.

2. 21st Century Cures Act Implementation

The Office of the National Coordinator for Health Information Technology (ONC) is advancing interoperability rules and addressing information blocking. These rules will likely modify certification requirements for health IT developers and promote better data sharing across platforms.

• Opportunities:

• Health IT developers should prepare for expanded requirements under the ONC Health IT Certification Program, ensuring their systems align with interoperability standards.

• Vendors offering patient data-sharing solutions can capitalize on increased demand for secure, compliant technologies that enhance information flow.