AI in Healthcare Compliance: Everything Leaders Should Know
Healthcare leaders face a dilemma: while a growing body of research demonstrates how artificial intelligence (AI) can improve diagnostics, reduce costs, and give providers more time to focus on patients, the general public is unconvinced. There are fears around safety and ethics that will not go away.
Leaders of healthcare organizations can resolve these issues through comprehensive compliance measures that reassure patients and enable the safe and effective adoption of AI. But with regulators scrambling to keep up with the evolving technology, what does compliance actually look like today, and how will it continue to change?
This article explores those questions and provides everything healthcare leaders need to navigate AI in healthcare compliance.
AI in Healthcare: Why Compliance Teams Should Care
AI is currently the most transformative evolution in modern healthcare. Early research demonstrates that AI-driven tools can improve almost all areas of care – from improving diagnostic precision and analytics to automating repetitive processes to give providers more time to focus on patients.
This has created a booming industry: over $31 billion was invested in AI-driven healthcare solutions between 2019-2022, and more than 70% of payors, providers, and healthcare services and technology (HST) groups are already pursuing generative AI solutions.
Those who have adopted AI solutions in the last few years have already seen quantifiable benefits. One health center used AI to identify high-risk patients likely to miss appointments and deliver targeted reminders. As a result, they reduced no-shows by 34%.
The problem is that these benefits come with attendant risks, and consumers and healthcare professionals are both concerned. About 60% of Americans are uncomfortable with providers relying on AI for care, making it harder to justify a full embrace of the technology – and placing pressure on compliance teams to ensure the safe adoption of these cutting-edge tools.
The Challenges: How AI Will Create Healthcare Compliance Challenges
1. Product Due Diligence
Nearly 1,000 AI-driven medical devices have thus far been approved by the FDA, and far more should be expected. Vetting these products to ensure they meet regulatory requirements and do not create vulnerabilities within your existing IT ecosystem will not be simple; AI presents a range of new security challenges, as evidenced by the National Institute of Standards and Technology (NIST) ‘s decision to create a new risk management framework specifically to combat the threat of AI.
Let’s take a simple example: HIPAA compliance requires robust protections for patient data, with most organizations reporting ongoing challenges meeting these standards. However, many AI solutions require access to large volumes of patient data to function; this could easily lead to unauthorized access or disclosure, which would qualify as a HIPAA violation.
Leaders must either develop new due diligence processes or adapt existing policies to reflect the potential risks of AI products.
2. Adapting Policies and Procedures
Many organizations will introduce AI products that can safely leverage patient data, but this will still require consent from patients. Compliance leaders will, therefore, need to implement processes to ensure every patient is informed of the use of their data.
This may be as simple as revising existing waivers, but a recent meta-analysis of the challenge cited significant legal and ethical barriers that may require new policies to address patient consent around the use of their data in AI models.
Equally, many organizations are not fully aware of their existing compliance program’s efficacy. In these cases, introducing AI will be an opportunity to evaluate existing processes and ensure they align with existing regulations and are actually followed by staff.
3. Navigating Evolving Regulations
The rapid rise of AI has taken regulations off-guard, and there is currently a wave of new plans to create safe parameters for AI in healthcare. More than 120 bills are currently being considered by Congress, meaning AI policies will likely have to adjust over the coming years. This will put a premium on flexibility and strong compliance foundations to enable organizations to respond quickly to new compliance requirements.
Ultimately, 13% of organizations have already hired an AI compliance specialist to tackle these issues. But It’s important to remember AI is not only a compliance challenge – it can also be a powerful compliance tool.
The Benefits: How Leaders Can Leverage AI to Enhance Compliance
There are numerous possibilities for AI to support compliance teams – with a new generation of so-called “RegTech.” Compliance teams should expect AI to help them:
- Automate Processes: AI tools can automate any repetitive process that relies on pattern recognition. While few organizations will entrust risk assessments or HIPAA audits exclusively to machines, they can work in tandem with trained humans to accelerate and enhance these processes and save a lot of time.
- Generate Materials: Healthcare organizations require a lot of compliance materials – from updating your code of conduct to creating regulatory documentation. Generative AI will lighten this burden and make it easier to produce a larger volume of compliance materials.
- Detect Threats: Cybersecurity often descends into a “cat and mouse chase,” where security teams must keep up with ever-evolving criminal tactics. However, AI will help detect potential vulnerabilities faster and identify behavioral patterns that could indicate a threat, helping organizations stay ahead.
The challenge will be selecting and implementing these tools effectively. Most organizations will need external support to understand the landscape and create effective strategies for implementation – which is exactly what Strategic Management Solution (SMS) can offer.
Our expert team provides targeted support across every area of healthcare compliance, ensuring you have the skills and knowledge required to meet every regulation with confidence. From evaluating your existing program to helping you assess evolving AI threats, we reduce the burden of compliance and protect your patients, reputation, and bottom line.
Worried about how AI will change your compliance requirements?
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