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Three potential compliance concerns to watch for in the digital healthcare arena

On Behalf of | Jan 18, 2024 | Health & Health Care Law |

The COVID-19 pandemic catalyzed growth in the digital healthcare sector but experienced a plateau in 2023. A recent report digging into this area of healthcare found that most startups looking to take advantage of the industry were not as successful as their founders had hoped. Instead, many needed additional funding. Experts predict that these start-ups will “find their footing” in 2024 and the market for digital health will continue to grow.

These same experts predict 2024 will likely see a surge in merger and acquisition deals, including a mix of start-ups joining forces and larger corporations purchasing promising start-ups to expand their reach within this field.

Those looking to take advantage of the growth in this sector of healthcare are wise to tread carefully. Regulatory compliance is important and an evolving concern within this area of healthcare. The concerns are complex and can include:

  • Patient confidentiality. The ability to make use of digital tools to improve patient care and diagnostics are well known. However, it is important to make sure to use these tools wisely to ensure patient confidentiality and avoid allegations of a Health Insurance Portability and Accountability Act (HIPAA) violation.
  • Proper approval. The United States Food and Drug Administration (FDA) will likely play a role in the approval of use of some technology. The process is complex and generally applies if the tech qualifies as a device. Certain types of AI and machine learning software may qualify.
  • Payment structure. The government is particular when it comes to paying out claims. A failure to follow the rules can result in allegations of a violation. Physicians and healthcare leaders are wise to review the Anti-Kickback and Stark Laws to make sure their relationships with providers do not constitute a violation and lead to allegations of illegal kickbacks.

This is an evolving area of the law. As such, healthcare providers are wise to stay agile and review their practices on a regular basis to ensure they follow applicable regulations.

Attorney John Rivas is responsible for this communication.

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