HIT Execs Prepare for a Shifting Regulatory Landscape

Mari Savickis, VP, Public Policy, CHIME

As the winds of change sweep through Washington, D.C., healthcare IT executives must prepare for a shifting regulatory landscape. With a new administration and congressional majority poised to reshape federal priorities, organizations like CHIME are focused on ensuring their members’ voices are heard. Mari Savickis, CHIME’s Vice President of Public Policy, recently provided insights into the challenges and opportunities facing healthcare IT leaders in this dynamic environment.

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A Shifting Regulatory Landscape: What to Expect

Every four years, the healthcare industry braces for potential shifts in federal policy as administrations transition. According to Savickis, “The policies under one administration often won’t align with those of its successor, especially when there’s a change in party leadership. This creates a landscape that’s constantly shifting underneath us.”

A critical focus for CHIME and its members is understanding how impending regulatory changes will impact their operations. For example, the Biden administration’s AI executive order and other recent initiatives may face revision or repeal. As Savickis points out, “The Congressional Review Act (CRA) gives a new administration the ability to roll back rules they view as burdensome or misaligned with their priorities.”

Healthcare IT executives should anticipate a regulatory environment with fewer mandates but increased scrutiny of compliance with remaining standards. This approach, aligned with Republican priorities, could significantly impact how healthcare organizations allocate resources to meet the shifting regulatory landscape.

The Chevron decision by the Supreme Court earlier this year, which limits agencies’ power to issue sweeping mandates, also adds complexity. Savickis explained that this ruling forces federal agencies to carefully craft regulations to avoid legal challenges, potentially slowing the release of new rules and standards. “Regulatory folks need to think twice about overreaching,” she said. “That creates a climate where regulatory burdens may actually decrease in the near term.”

Telehealth and Cybersecurity: Top Concerns

Among the immediate issues on CHIME’s radar are telehealth policies and cybersecurity initiatives. The looming December 20th deadline for government funding brings uncertainty about whether telehealth extensions will be part of a continuing resolution. These extensions, vital to the widespread use of telehealth, remain a point of contention between parties. “Telehealth isn’t free,” Savickis explained. “It comes at a cost to the federal government, so there’s an ongoing discussion about how to fund these critical services.”

Savickis, however, is confident that an extension of at least two years is on the way.

Cybersecurity remains another pressing concern. The escalating frequency and sophistication of cyberattacks make this an urgent issue, particularly for underfunded providers. CHIME has engaged with policymakers to support the Healthcare Cybersecurity and Resiliency Act of 2024, which proposes grants and standards to bolster cyber defenses. “Cyber is our top priority,” Savickis emphasized, noting the disproportionate impact of cyber threats on rural and underserved providers. “You don’t want to see a cyberattack take down the weakest link.”

The legislation includes funding opportunities for resource-constrained organizations, such as those in rural areas, to improve their cybersecurity infrastructure. For health systems, especially those operating in underserved regions, staying informed about these potential grants will be essential.

Navigating the Challenges of AI and Privacy

AI offers tremendous potential but also poses significant challenges, particularly in areas like privacy and clinical decision-making. “The sandbox where healthcare operates must be protected,” said Savickis, highlighting concerns about safeguarding sensitive patient data from being inadvertently exposed through AI tools.

One of the most critical challenges lies in the absence of a national AI law or privacy standards. This regulatory void has left states to develop their own rules, creating a complex patchwork of regulations for healthcare providers operating across state lines. Savickis advises CIOs to stay informed about state-level activity, as the momentum for localized legislation is growing.

The lack of clarity at the federal level complicates compliance for multi-state providers, who must navigate varying state laws. As Savickis pointed out, this regulatory fragmentation “makes things really tough,” particularly for organizations drawing patients from across the country. She emphasized the need for a national privacy standard, though she admitted the political climate does not seem conducive to such legislation in the short term.

In addition to privacy, AI’s application in clinical decision-making remains a cautious frontier. Executives should be mindful of AI’s limitations and risks, especially in contexts involving sensitive health data or clinical recommendations.

Reducing Regulatory Burdens

Healthcare IT leaders often cite regulatory burden as a major contributor to operational inefficiencies and workforce burnout. CHIME aims to capitalize on the current administration’s preference for deregulation by identifying and advocating for the removal of outdated or overly burdensome policies. Savickis noted, “We need to navigate the regulatory morass and make things cleaner to free up resources for critical areas like cybersecurity and workforce development.”

A significant portion of these burdens stems from documentation requirements for compliance and reporting. These not only strain IT systems but also contribute to clinician dissatisfaction and burnout. By streamlining these processes, health systems could redirect resources to areas of higher impact, such as patient care and technological innovation.

CHIME plans to survey members to prioritize the regulatory changes they believe would have the greatest impact. By aligning their advocacy with these priorities, CHIME hopes to reduce administrative overhead and enhance the overall efficiency of health systems.

Preparing for the Future

Healthcare IT executives must prepare for a year of both uncertainty and opportunity. Savickis advised CIOs to focus on practical strategies that align with emerging priorities, including:

Monitor Federal and State Policies: Stay informed about legislative and regulatory developments at both levels, particularly regarding AI, privacy, and cybersecurity.
Engage in Advocacy: Participate in CHIME’s initiatives to influence policies that align with the needs of health systems.
Focus on Cybersecurity Resilience: Prioritize investments in cybersecurity, especially for rural and underserved providers, to mitigate risks and protect patient data.
Leverage AI Responsibly: Explore non-clinical applications of AI to enhance operational efficiency while adhering to strict privacy safeguards.
Identify Regulatory Pain Points: Contribute to CHIME’s survey to help prioritize the removal of policies that create unnecessary administrative burdens.

By staying proactive, healthcare IT executives can not only adapt to changes but also position their organizations for success in a shifting landscape. Collaboration between policymakers and industry leaders will be crucial to ensuring that innovation and patient care remain at the forefront of the healthcare agenda.

Closing Thought

Savickis ended with a call to action for CIOs and IT leaders: “Let us know your pain points. Together, we can navigate this shifting regulatory landscape and advocate for policies that truly support our mission.”

For more insights from CHIME click here.

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