Navigating New Frontiers in Healthcare Compliance in 2024

The ever-evolving landscape of industry compliance enters uncharted waters

29th May 2024

Healthcare organizations often face the dual challenge of safeguarding patient data while embracing innovations promising to enhance efficiency and effectiveness in healthcare delivery.

Axios International specializes in the design and implementation of sustainable access to healthcare solutions, with a particular focus in emerging markets and low- and middle-income countries. Our expertise in understanding the entire spectrum of the patient journey requires us to identify and mitigate a wide range of compliance issues.

For that reason, staying on top of new regulations and trends affecting the compliance space is a cornerstone of our business model and how we serve patients. Here, we explore the key trends shaping the compliance landscape and best practices for maintaining compliance in this rapidly evolving sector.

Technological Innovations and Compliance

AI and Compliance

No conversation about healthcare technology is complete today without mentioning the impact of artificial intelligence (AI). Morgan Stanley recently reported that the amount allocated to AI and machine learning (ML) by healthcare entities is anticipated to be 10.5 percent this year, more than double that of 2022. The bank contends that 94 percent of healthcare companies are using either AI and/or ML in some capacity. As a result, AI has the potential to directly influence healthcare compliance by helping to streamline key processes while enhancing data analytics capabilities.

The potential deployment of AI in compliance processes, however, introduces several complexities, particularly around data privacy and ethical considerations. The European Union’s new legislation on AI aims to ensure safety and adherence to fundamental rights, something that will influence benchmarks for global standards, yet this will still take time to be replicated in other key regions. The U.S. government has outlined its own requirements for AI systems to enhance privacy and prevent bias. The underlying message in these regulations is the importance of aligning AI deployment with existing legal frameworks to mitigate risks and enhance patient care outcomes.

Building a Reliable Compliance Program in the Age of AI

To ensure a strong compliance framework in a healthcare organization implementing AI, the Office of the Inspector General (OIG) in the U.S. Department of Health and Human Services suggests that the following elements should be present in an organization’s AI compliance strategy:

  • Implementing written policies
  • Designating a compliance officer and, if possible, a committee
  • Providing effective training
  • Establishing communication channels
  • Performing internal audits while enforcing disciplinary guidelines.

A healthcare organization will also need to establish a structured approach for departments wishing to implement AI that enables comprehensive risk management while meeting business needs. This involves identifying relevant internal and external stakeholders (including Board members with practical AI experience), selecting partners aligned with organizational values, and setting clear data governance standards.

Enhancing Data Security through Cybersecurity Measures

With the increasing adoption of digital health technologies like AI, cybersecurity is fast becoming a significant component of healthcare compliance. The increase in global cyberattacks has put a spotlight on healthcare, with it being a prime target due to the sensitive nature of its data. Last year, the World Economic Forum revealed that the healthcare industry alone reported data breaches which cost an average of $10.93 million per breach - almost twice that of the financial industry. To protect against attacks in an age of AI, it is imperative that healthcare organizations employ the latest cyber security protocols and parameters that are aligned with both their local government guidance and global standards.

At Axios, protecting patient data confidentiality is one of our most critical responsibilities. Ahmed El Hassan, Head of Quality, Compliance and Ethics at Axios International, says that patients have the right to control their personal data and make decisions about its use and disclosure.

“Axios fully respects patients’ autonomy by obtaining their informed consent for the collection, use, and sharing of their data and honoring their preferences regarding privacy settings and data sharing. From collection to data sharing, it is guided by the individual's informed consent. Patient autonomy is pivotal in nurturing a trust-based relationship between healthcare providers and patients, a trust that is integral to the integrity of the healthcare system and the efficacy of the patient treatment journey,” says Ahmed.

By prioritizing informed consent and respecting patient preferences, Axios reinforces the trust that is foundational to the patient-provider relationship and crucial for a seamless and effective treatment journey.

Regulatory Changes and Compliance Requirements

Updates to HIPAA Regulations

The Health Insurance Portability and Accountability Act (HIPAA) regulations have undergone several recent updates aimed at enhancing patient rights and facilitating better access to personal health information (PHI). Key changes include reducing the response time for PHI requests and simplifying the process for patients to direct their PHI to third parties. The upcoming 2024 HIPAA revisions have clearly taken a hard line when it comes to patient data safety, with a focus on equipping patients with the ability to control their health data. Patients can now obtain copies of their records in electronic form and can ensure corrections and/or amendments to inaccurate information can be requested.

Ethical Compliance and Sustainability

Early last year, the EU introduced its Corporate Sustainability Reporting Directive (CSRD) and Corporate Sustainability Due Diligence Directive (CSDDD) which was a watershed moment in ethically responsible business practices in healthcare. These directives require healthcare organizations to assess and mitigate their impact on human rights and the environment. The resulting goal of greater transparency and accountability is meant to encourage new, more stringent compliance benchmarks that global healthcare providers must meet if they are to be seen as ready for the technological advancements that are at their doorstep.

Considerations Moving Forward

Healthcare organizations must put in place advanced compliance solutions to ensure their practices align with the evolving digital landscape and the latest standards and regulations. This can help safeguard their operations so they can continue to deliver safe and ethical healthcare services to the patients they serve. Looking ahead, the best performing, and most trusted healthcare organizations will be those that patients can rely on.