Healthcare Compliance Challenges and Solutions in 2024

The healthcare industry is experiencing a surge in regulatory and enforcement activities, according to an article by Navex, impacting not only hospitals and nursing facilities but also non-healthcare entities like technology companies. Several key initiatives are either in effect or forthcoming:

Increased Penalties for HIPAA Violations: Stricter penalties are being imposed for violations of the Health Insurance Portability and Accountability Act (HIPAA).

Scrutiny of Anticompetitive Practices: New policy initiatives are focusing on examining anticompetitive practices within the healthcare sector.

Healthcare-Specific Cybersecurity Requirements: Enhanced cybersecurity regulations tailored to the healthcare industry are being introduced.

Oversight of Private Equity Firms: Ownership structures of private equity firms in healthcare are under heightened scrutiny.

Regulations on Artificial Intelligence: New regulations are being implemented to govern the use of artificial intelligence in healthcare.

This surge in regulatory activity requires heightened attention from compliance officers and their legal counsel across various healthcare sectors.

The U.S. Department of Health and Human Services (HHS) is not the only agency enhancing oversight; other federal bodies like the Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Cybersecurity and Infrastructure Security Agency (CISA) are also stepping up their monitoring efforts.

One particular area of focus is the use of online tracking technologies by healthcare organizations, especially concerning the disclosure of sensitive personal health information (PHI) to third parties. Both the Office for Civil Rights (OCR) and the FTC have issued warnings and are enforcing compliance with HIPAA rules regarding these technologies.

Moreover, the HHS Office of the Inspector General (OIG) has released comprehensive General Compliance Program Guidance (GCPG), providing a roadmap for healthcare compliance. It emphasizes the importance of adherence to federal healthcare laws and outlines the “seven elements” of a robust compliance program, offering guidance for both large entities and smaller organizations with limited resources.

Overall, compliance with HIPAA rules is highlighted as a priority, and new entrants, including technology companies, are advised to understand the intricacies of healthcare compliance to avoid potential liabilities. The GCPG serves as a practical tool for establishing effective compliance programs in the healthcare industry.