HHS (HTI-1) Final Rule on AI Transparency

HHS (HTI-1) Final Rule on AI Transparency

The HHS released is final rule on AI transparency in December 2023. Since its inception, Altheia has been developing our product, Acuvia, with the intention of complying with future rules like this one, as we’ve been anticipating that scrutiny around AI use for decision support in healthcare would continue to grow.

In the first half of this year, we will begin our clinical trial with Acuvia, which is designed to address many concerns around AI use. We will have a 3rd party publish their results of our study, and with our own internal testing, we believe we will be compliant with the regulations as we go to market in 2025.

Here is a summary of the regulations and how Acuvia will comply with them.

  1. “HHS’ leading-edge regulatory approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.”

Acuvia addresses this in several ways. First, a common dataset is used to ensure that the same information is aggregated for a given population. Second, all information is ingested from valid sources with the individual’s consent. Third, all HIPAA and privacy rules are followed, and the data is secure.

  1. “This initiative introduces transparency requirements for certified health IT and software developers, particularly focusing on AI and predictive algorithms such as models that analyze medical imaging, generate clinical notes and notify clinicians of potential risks to patients.”

Acuvia generates risk profiles for individuals for 5 chronic diseases. Our predictive models use claims, clinical, and social determinants of health data consented for use by the individuals, who also can augment the dataset with additional information. The member can view all the data used in the creation of their risk profile. Acuvia also presents them with an accuracy metric of how certain the algorithm is about the result. Together, those 2 pieces of data are very useful to help individuals talk to their primary care physicians about their next steps.

  1. “Under the rule, developers must provide organizations with details on the software’s development process and functionality. This includes disclosing funding sources, specifying its intended role in decision-making and providing guidelines on when caution is warranted for clinicians using it.”

Acuvia is an independent utility leveraging member-consented data with the ability to deliver risk stratification results to all stakeholders in the healthcare ecosystem. Its purpose is to provide an accurate assessment of clinical risk associated with 5 chronic diseases, which can be used by both clinicians and individuals to determine the best plan of care to mitigate the effects of disease. The one area where we suggest caution is for the approach used by clinicians from care and disease management companies. Discussing risk for chronic disease with someone who is just finding out that they need to work with their physician on a care management plan requires a well-trained clinical staff equipped to support those critical discussions.

  1. “Developers will also need to inform customers about the AI’s training data. Additionally, they will be required to disclose performance metrics, elaborate on ongoing performance monitoring procedures and outline the frequency of algorithm updates.”

Acuvia has full documentation on all data that was used to train our MVPs for Cardiovascular Disease, CKD, Hypertension, Diabetes and COPD. We also provide an array of reporting at the individual level for individuals as well as at the population segment and full customer levels, including ongoing performance monitoring. Our algorithms use ML and become smarter over time. Our current market approach includes an annual update of all algorithms to ensure our customers will get our most recent versions.

Our product, Acuvia, will move into clinical study and pilot phases in the first half of 2024. We had anticipated that further scrutiny around AI was forthcoming in 2023, so our strategy has been to ensure our product goes through a 3rd party review and is compliant with all rules and regulations related to AI and data security as it enters the market.

We look forward to providing more updates as we launch our clinical study.

Leveraging AI for Inclusive Healthcare Solutions

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From the desk of Lisa Fridland, Altheia’s COO.

I’ve been working with AI powered solutions for almost 15 years. In the beginning, the focus was on automation and trending to statistically support decision making as part of my operational roles. Later, I moved into working with predictive analytics and other more advanced AI solutions. From the beginning, the eventual power of AI and its ability to accelerate change was obvious. For me, it’s been an incredible journey to witness AI capabilities grow during this timeframe.

In today’s rapidly evolving healthcare landscape, the integration of Artificial Intelligence (AI) has emerged as a transformative force, promising a revolution in the way we approach medical care. With its potential to enhance accessibility, efficiency, and quality of healthcare services, AI is at the precipice of routinely being used to power inclusive solutions that cater to diverse populations. The intersection of AI and healthcare not only offers innovative tools but also presents a clear opportunity to address healthcare disparities and foster inclusivity.

Bridging Accessibility Gaps

AI-driven technologies have the capacity to bridge geographical and financial gaps in healthcare access. Telemedicine, empowered by AI, enables video and asynchronous consultations, diagnosis, and monitoring, providing healthcare access to underserved and remote communities. According to the NIH, telemedicine has shown substantial success in improving access to healthcare services, especially in rural areas where medical resources are scarce.

Personalized Care and Diagnosis

AI algorithms can analyze vast datasets to generate personalized treatment plans and predictive models. This supports the creation of tailored care plans that incorporate individual differences, including genetic predispositions, socio-economic factors, and cultural variations. For instance, AI-powered diagnostic tools like IBM Watson have exhibited accuracy in identifying diseases, thereby reducing misdiagnoses and ensuring equitable treatment for diverse populations.

It is in this space our product, Acuvia, firmly resides. Specifically, Acuvia will prioritize member outreach within a population based on not just diagnosed populations, but it will prioritize across all members based on risk profiles. That’s a major shift in approach for any entity doing case management and anyone seeking to manage population health and care intensity.

Enhancing Cultural Competence

This research paper from Johns Hopkins University discusses why cultural competency in healthcare is crucial for effective communication and understanding diverse patient needs. AI language processing tools equipped with natural language understanding capabilities can aid in translation services, enabling healthcare professionals to communicate with patients in their preferred language. Moreover, these tools can assist in recognizing cultural nuances, facilitating a more empathetic and culturally sensitive healthcare approach.

Challenges and Ethical Considerations

While AI holds immense promise in fostering inclusive healthcare, certain challenges and ethical considerations need to be addressed. Biases within AI algorithms, if left unchecked, can exacerbate existing disparities and perpetuate inequality. Therefore, it is imperative to continuously audit and refine these algorithms to ensure fairness and inclusivity across diverse demographics. It’s important to point out that those audits should be done by diverse teams of people and that the auditing team members aren’t consistently auditing the same algorithms. Equity and inclusion has to be a strategy at every step. Back in August, Jolly Nanda, our CEO and Founder, wrote a blog post talking about bias in AI and how to ensure that it’s not exacerbated.

Beyond bias, data privacy and security remain paramount. Safeguarding sensitive patient information is crucial to maintain trust in AI-enabled healthcare solutions. Comprehensive regulations and frameworks must be established to protect patient confidentiality and prevent misuse of healthcare data. From a practical application perspective, using the right tools at the right time and making sure those leveraging the tools are well-versed in their capabilities ensures that data is being used as disclosed.

Our product, Acuvia, directly addresses these challenges by leveraging clear communication about how data is being used, who can access it, and how it will be used in the creation of personalized risk profiles across our predictive models. Members choose to opt in, ensuring they’re in full control of their own data.

Future Prospects

As technology continues to advance, the synergy between AI and healthcare presents limitless possibilities. Collaborative efforts among healthcare professionals, policymakers, technologists, and ethicists can drive innovation while ensuring that AI solutions prioritize inclusivity and equity.

AI will be a catalyst for groundbreaking advancements, such as predictive analytics for early disease detection, personalized treatment regimens, and automated healthcare interventions. These innovations will not only revolutionize medical practices but also democratize healthcare, making it more accessible and equitable for all.

Acuvia, as we bring it to market, provides members and customers real-time risk assessments across 5 chronic diseases, which can be used to personalize intensity of care and enables members to intervene in their own predicted health outcomes. This begins to level the playing field across demographics because nothing is left open to interpretation – Acuvia provides both the risk profile and the corresponding expected accuracy of the prediction. Members can use this to discuss their health with their doctor, secure in the knowledge that they have a clear interpretation of the claims and clinical data being used to assess their health.

The integration of AI in healthcare holds tremendous potential to revolutionize the industry and change the way patient-centered care is delivered. As AI continues to evolve, the potential for inclusive healthcare solutions expands exponentially. The key lies in harnessing this technology responsibly and ethically, ensuring that it benefits everyone, regardless of background or circumstance.

In this era of technological innovation, the union between AI and healthcare stands poised to redefine the future of medicine—one that is inclusive, empathetic, and accessible to all.

2024 MN Angel Tax Credit Certified

2024 MN Angel Tax Credit Certified

As a minority-owned, women-led business, we’re thrilled to announce that our company has been granted the 2024 Minnesota Angel Tax Credit certification status! This recertification is a testament to our innovative approach and the hard work of our dedicated team. 
For investments made with us in both 2023 and 2024, Minnesota’s Angel Tax Credit provides a 25% credit to investors or investment funds making equity investments in startup companies focused on high technology, new proprietary technology, or a new proprietary product, process, or service in specified fields.
This program has been instrumental in supporting startups and small businesses like ours, providing us the financial resources we need to drive innovation and create a lasting impact in our industry. This credit will fuel our growth, enable us to push boundaries, and continue contributing new innovations to our industry.

The Case for Investing in Health Literacy

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From the desk of Jolly Nanda, Altheia’s CEO.

As someone who has always been passionate about improving healthcare and providing individuals with knowledge they need to make educated decisions, I’m excited to delve into a topic that holds immense promise and potential – the economic benefits of investing in health literacy programs. Not only do these programs have a profound impact on individual well-being, but they also have the power to transform a broader economic landscape. In other words, it’s not just about better health; it’s also about a healthier economy.

Health literacy is more than just understanding medical jargon; it’s about equipping individuals with the skills and knowledge needed to make informed decisions about their health, understand the information being provided to them, and to be able to navigate an increasingly complex healthcare system. Some of the benefits of improved health literacy are better decision making, improved communication between patients and providers, increased engagement – especially around preventative care, a reduction in health disparities that improves public health, and lower health care costs.

Research has shown that low health literacy is associated with higher healthcare costs, more frequent hospitalizations, and even lower overall economic productivity. In contrast, improving health literacy can reduce these costs and create a healthier, more productive population.

Success Stories in Health Literacy

Let’s take a moment to celebrate the incredible achievements of organizations that have invested in health literacy initiatives. One remarkable success story comes from the “Plain Language Health Information” project in Australia. By simplifying medical information and making it more accessible, they have empowered individuals to take control of their health. This program has not only resulted in better health outcomes but also saved millions of dollars in healthcare costs.

Another success story that stands out is the “Ask Me 3” initiative implemented by the Institute for Healthcare Improvement (IHI). By promoting the simple concept of encouraging patients to ask three vital questions during their healthcare visits, the IHI witnessed significant improvements in patient understanding and engagement. This translated into fewer medical errors, reduced hospital readmissions, and, importantly, lower healthcare costs. For every dollar invested in the “Ask Me 3” program, there was a return of $32, demonstrating the immense cost-saving potential of improving health literacy.

Another inspiring example is the “Text4Baby” program in the United States. By providing expectant mothers with timely health information via text messages, the program has led to healthier pregnancies, fewer premature births, and substantial cost savings in neonatal care. These initiatives demonstrate the immense potential of investing in health literacy.

At Altheia, we’re launching our new SaaS product, Acuvia, which will establish a framework for us to use to build more post-launch functionality that will be designed specifically to address both health equity and health literacy. Our MVP predictive models already include expanded health equity data that is unmatched in the current market. Our long-term road map includes additional predictive data set expansion and more focus on taking our predictive results and helping our members better understand how to approach improving their health. Expanded data will drive better, more personalized results and provide better insights to both customers and members will significantly improve outcomes.

For those interested in funding health literacy initiatives, here’s a roadmap to guide your efforts:

A Roadmap for Stakeholders

  1. Identify Key Partners: Collaborate with healthcare providers, government agencies, and community organizations to create a robust support network.
  2. Assess the Need: Identify the specific health literacy needs of your target population. Use surveys and data to pinpoint the most pressing issues.
  3. Develop Clear Objectives: Set clear, measurable goals for your health literacy program, whether it’s improving patient communication, enhancing health education materials, or training healthcare staff.
  4. Invest in Education: Provide training to healthcare professionals on effective communication and plain language techniques. Ensure they understand the value of health literacy.
  5. Engage the Community: Partner with community leaders and organizations to raise awareness and build trust.
  6. Advocate for Policy Change: Support policies and initiatives that promote health literacy and clear communication in healthcare.

The economic benefits of investing in health literacy programs are undeniable, and the success stories of organizations like the IHI and Text4Baby serve as proof that these investments can lead to significant cost savings. If you’re a stakeholder interested in funding such initiatives, follow the roadmap above to ensure your resources are well-utilized and the benefits are maximized. Not only will you help people lead healthier lives, but you’ll also be contributing to a healthier economy.

Alternatively, at Altheia, we’re still in our seed funding round. An investment with us will help us introduce a solution that will make significant contributions to health equity and health literacy initiatives in health care. Investments in 2023 are eligible for a 25% tax credit from the state of Minnesota, irrespective of where the investor resides. If interested, email us at info@altheia.com.

For those who like to delve into the data, several sources provide comprehensive evidence of the economic benefits tied to health literacy:

Data Sources and Evidence

  1. The Agency for Healthcare Research and Quality (AHRQ) is a treasure trove of studies and reports. They consistently publish findings on the relationship between health literacy and health outcomes, with a focus on cost savings.
  2. The Institute of Medicine (IOM) offers reports and publications that explore the economic implications of low health literacy. They highlight how investments in health literacy can lead to a more efficient and cost-effective healthcare system.
  3. Health Literacy Studies by the Health Literacy Studies research group provide in-depth analyses of the relationship between health literacy and healthcare utilization, cost, and quality.

Investing in health literacy is not just a moral imperative, it’s a smart economic choice. By giving individuals the knowledge to make informed health decisions we can reduce healthcare costs, improve individual well-being, and ultimately foster economic prosperity. The success stories of organizations that have already taken this path serve as a testament to the immense potential of health literacy programs.



Health Equity and Health Literacy

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Altheia Amplified | Episode 4: A Discussion about Health Equity and Health Literacy

by Altheia

Thank you for checking out our podcast, Altheia Amplified.

In this episode, we invite you to listen in and hear our CEO and Founder, Jolly Nanda and Lisa Fridland, our COO and Co-Founder, have a discussion about health equity and health literacy and how they intend for Acuvia to part of a long-term industry solution to level the playing field and improve outcomes.

As a reminder, we continue to raise funds for our seed round and investing with us does come with a 25% tax credit from the State of Minnesota for investments made in 2023. If listeners are interested in investing in Altheia, they can reach out to Scott Taylor by emailing Scott@Altheia.com. For more information on Minnesota’s Angel Investor Tax credit, click here

Length: 9 minutes 44 seconds