McLendon IP specializes in Artificial Intelligence (AI) services for the healthcare marketplace built upon nearly 5 decades of experience. Please contact us or our partner Comply Assistant to discuss your ideas and projects.
Senior Leader AI Training
Senior leaders from organizations of all sizes, providers, payers, and supporting vendors typically have many questions about the risk and compliance of the AI systems or components they have procured or are planning to, along with natural fears that have been reinforced about AI in general over time. McLendon IP excels at speaking to non-technical leaders about the realities of these systems in terms they understand and ties the governance and compliance their organizations already perform with the emerging requirements for AI governance and compliance.
In as little as an hour, but longer if desired, McLendon IP can deliver a knowledgeable PowerPoint based educational session from our viewpoint of what the risk picture looks like for AI systems and data for healthcare entities in general. The presentation also includes actionable ideas for how to implement proper AI governance adding regulatory compliance as it evolves into requirements, rules, and regulations for healthcare entities.
This evolution has already started with FDA and Cures Act rule implementation.
This presentation can be a standalone project just for educational purposes or the beginning of a deeper project including formal assessment of your organization's risk from your AIs in use or being planned. Even if you have AI only through your EHR (Electronic Health Record) or RCM (Revenue Cycle Management) vendors your organization still must implement governance and compliance to surround and control them from your perspective in order to lower your own risk. McLendon IP can assist in getting those efforts rolling or fine-tuned.
Once the presentation is delivered it forms a basis for discussion. If you so desire, we can then discuss possible strategies for moving forward to ensure governance and compliance keep pace with AII use and innovation within your healthcare organization.
AI Assessment
In order to control liabilities introduced by various forms of risk, AI systems, components and their related data stores need to be evaluated for the risks introduced by each use case they operate within. Unlike traditional computer systems, AI systems are based on much different software and hardware tools and their output, or what is being used by your organization from them, is variable and can be changed by human actors or changes in technology, environment, societal influences, etc. This requires differing types of vendor selection, implementation, use and monitoring from the systems you are used to dealing with.
Mclendon IP has an Assessment methodology that assesses organization risk from all AI use and specific AI system, component and data store risks by each system or use care. Like a traditional security or privacy risk analysis, the McLendon IP / Comply Assistant AI Governance Assessment is a series of questions asked by our assessors with answers and supporting evidence input by the assessor and managed within the Comply Assistant's highly professional software application. After question completion, which is typically based upon a series of conference calls, a report is issued listing the results and associated risk levels.
At the end of the Assessment the software application can be utilized to remediate and continue documentation of the governance items required for not only the organization's overarching AI governance and compliance program, but also for each system as well.
AI Governance and Compliance Services
Senior leaders often have questions about the risks associated with adopting and using AI systems, components and data. While the AI vendors tout the benefits of their platforms, the risks remain largely undocumented or stuffed into already overly complex user agreements and documentation which is difficult for governance to ascertain. McLendon IP offers strategic planning and assistance building out your AI governance and compliance programs.
AI systems, capabilities, and data are unique but not entirely different from other areas of governance and compliance. For example, established areas of compliance and regulation such as NIST structured security and privacy risk management, HICP 405(d) cybersecurity frameworks, and generalized DOJ compliance risk management program elements, including HIPAA for healthcare, still apply.
However, AI systems and capabilities differ from traditional governance and compliance in that their input data changes over time, and the way they compute answers and suggestions also changes over time. This requires continuous structured monitoring and risk adjustment.
McLendon IP has completed building our comprehensive AI system and data Assessment with a focus on governance and compliance. This was accomplished ahead of most of our competitors by performing a comprehensive environmental scan of the NIST AI RMH 100-1 and its companion 600-1, the HIPAA rules, the NIST frameworks, the Cures Act HTI-1 rules, Biden’s AI Executive Order, FDA 510(k), HHS Trustworthy AI Playbook and several other credible sources. We combined these with our extensive past history of healthcare compliance assessment technologies and their use with customers. We are very accomplished healthcare governance and compliance assessors.
The result is an AI system and data Assessment that targets not only the organization that procures and manages the AIs, but also details about each use case, system or instance of AI being used or planned for deployment.
Prospective customers include providers of care and payers, as well as their supporting vendors that provide the AI functionality. If the AI functionality is built in-house, the same rules and AI Assessment applies.
In many cases, our AI Governance Assessment will rely on answers provided by the AI vendors directly or through their license agreements. The data requested within our Assessment by and large required to be published by the AI vendors, but it may be laborious to obtain, if they have it at all. McLendon IP’s assessment methodology combined with our software powered by Comply Assistant, can assist in getting the responsible vendors the correct sets of questions to answer to meet the guidelines established by NIST and other organizations, including upcoming and existing regulators.
We offer comprehensive services to help healthcare organizations understand and establish effective AI governance. While AI is a complex and rapidly evolving field, fundamental compliance principles can be applied proactively—even before regulatory requirements mandate it. Contact us for more information on how we can support your organization in navigating the AI landscape, or for customized training services at mclendonip@outlook.com.