Howard Rosen

Navigating Real-World Evidence for Health Technology Assessment: Key Insights from Industry Experts 📊🔍 *The recent webinar featuring insights from April Betts (UCB), Stephen J. Duffield (NICE), and Rachel Cummings (Decisive Consulting) provided an in-depth look into the evolving role of real-world evidence (RWE) in health technology assessments (HTAs). Here are the key takeaways: ✔ Evolution and Importance of RWE: RWE is becoming a staple in healthcare, impacting regulatory decisions and market access. It addresses gaps inherent in randomized controlled trials (RCTs) by providing data on larger populations and real-world practices. 🌐🧬 ✔ Challenges and Opportunities: The integration of RWE faces challenges such as data quality, relevance, and regulatory acceptance. However, it presents opportunities to enhance evidence for HTAs, especially in demonstrating long-term effectiveness and safety. 🚧📈 ✔ Strategic Applications: RWE is critical in areas like cost-effectiveness analyses and can influence the decision-making processes of bodies like NICE. Effective RWE strategies involve early planning and continuous adaptation to evolving healthcare landscapes. 📝💡 ✔ Collaborative Efforts: Successful RWE utilization requires collaboration across various stakeholders, including academia, industry, and regulatory bodies. This collaboration helps ensure that RWE meets diverse regulatory requirements and adds value to HTA submissions. 🤝🌍 ✔ Future Directions: The use of RWE is expected to grow, with increasing sophistication in data analytics and broader regulatory acceptance. Stakeholders must remain agile and proactive in leveraging RWE to inform healthcare decisions and policies. 🔮📊 *These discussions highlight the critical role of RWE in shaping the future of healthcare decision-making, underscoring the need for strategic alignment and robust methodologies in its application. #HealthcareInnovation #RealWorldEvidence #HTA #Pharmaceuticals #HealthTech

2

Here’s your recap of last week’s health IT news 🗞️ 👇 🤖 AI Clinician Assistant • Avaamo launched an AI ambient scribe solution with support for over 50 specialties with pre-trained models. • Wound AI, an AI clinical decision support solution built by VANTIQ, Telemedicine Solutions, LLC, and NTT DATA, launched and is now available 📞 AI Contact Center • Premier Inc. awarded a group purchasing agreement to TeleVox Healthcare. 🏥 AI Facility Management • Medely has integrated with Oracle, allowing users to leverage Oracle’s Cloud HCM capabilities. 🌡️ AI Remote Patient Monitoring and Triage • The Alliance for Smart Healthcare Excellence—established by care.ai, now a part of Stryker, and developed with assistance from CHIME—was established to promote the Smart Hospital Maturity Model (SHMM). 📈 Data & Analytics • Epic expanded its set of APIs available to developers to support USCDI v3. • Health Catalyst will acquire Intraprise Health, a cybersecurity provider; it was also selected for analytics and interoperability by CyncHealth, Iowa’s health information exchange (HIE). • Health Commons Project acquired OneHealthPort • Socially Determined released a new application that helps organizations access data for minors. 🧾 Orders & Fulfillment • Surescripts is expanding its Medication History for Populations product to health plans, enabling care management teams to identify gaps in care and improve outcomes. 🧑‍💻 Virtual & At-Home Care • Mass General Brigham launched a partnership with the New England Center and Home for Veterans to provide hospital at home services for veterans experiencing homelessness. • MedStar Health expanded its partnership with DispatchHealth to support care transitions.    🍎 VBC • i2i Population Health is partnering with CureMD to surface actionable data to providers at the point of care. 🧠 Food For Thought • Brendan Keeler shared an interesting post differentiating AI solutions across augmentative vs. autonomous and then further breaking down each. One take we found interesting was, “Active interfaces are fun, but ultimately have some of the same problems as Siri - they require explicit engagement and cognitive overhead to use. This means their adoption and impact often fall short of expectations - users must actively remember to use them and overcome the friction of engagement.” https://lnkd.in/eR39qFpK --- Want the latest healthcare tech news delivered to your inbox each week? Sign up here 📬 👉 https://lnkd.in/e2UJ3ckP

34

Healthcare is at a turning point, and the stakes couldn’t be higher. The demand to deliver better care at lower costs is relentless, and the leaders who can unlock the transformative power of AI and data will shape the future of our industry. The question isn’t if data can drive change but who will lead that change. At Aetion, we help healthcare leaders rise to the challenge. Our AI/ML suite is designed to turn complexity into clarity, enabling bold decisions that improve outcomes, allocate resources smarter, and spark innovation. - Smart Risk Profiling: Pinpoint the drivers of cost and resource utilization to focus interventions where they matter most. - Measures Assistant: Simplify the creation of complex analytics, empowering teams to spend more time driving impactful insights. - Aetion Generate: Enable secure, privacy-compliant collaboration, opening new pathways for research and innovation.This is analytics with purpose—designed to tackle healthcare’s most pressing challenges and deliver meaningful, measurable results. The opportunity to transform healthcare with AI is here. At Aetion, we equip leaders to harness the power of their data with confidence, clarity, and impact—charting a future where every decision is informed by evidence. Please read the blog to learn how we empower leaders to shape healthcare’s future. Contact us to explore how Aetion can help you turn healthcare’s potential into measurable progress. https://lnkd.in/dpt3J4du

31

Now that our HIT industry has spent nearly 40 years figuring out how to effectively pass data between sites, settings, and institutions of care (and while that journey isn't completely over, we're well on our way), we can finally turn and look farther down the road and consider what's next. In my view, advancing process consistency, agility, and change is that horizon. The BPM community is focused on that challenge, and having recently transitioned into HL7 as HL7 BPM, is squarely trying to take this on. With today's press release, HL7 is truly open-for-business in this space. Thanks to the OMG for nurturing this work along and for HL7 for having made our next home for this effort. So much to do! https://lnkd.in/dAF96g3n

48

5 Comments

The Power of Data: How RPM Enhances Patient Outcomes Healthcare isn’t just about treating illnesses—it's about preventing them. Remote Patient Monitoring (RPM) is transforming chronic care management by enabling data-driven decisions that improve outcomes and patient satisfaction. At Vitasigns, our RPM solutions do more than just track vitals. They empower healthcare providers to: - Identify trends and risks early through real-time insights. - Deliver personalized care plans tailored to individual needs. - Foster better communication between patients and care teams. - Improve long-term health outcomes by promoting lifestyle changes. Imagine being alerted to a critical change in a patient’s condition before it becomes a crisis. With RPM, this is not just possible—it’s becoming the standard of care. Let us show you how Vitasigns can help your practice turn data into action. Together, we can elevate the level of care you provide and make a lasting impact. Discover the Vitasigns difference today. #DataDrivenCare #RemotePatientMonitoring #ChronicCareManagement #HealthcareInnovation #PatientCare #DigitalHealth #Vitasigns #HealthTech

11

This truly highlights the tension between innovation and market dominance in health tech. Particle Health's challenge against Epic could set a significant precedent for data interoperability and patient rights. As regulatory scrutiny on monopolistic practices intensifies, it will be interesting to see how this unfolds.

2

Digital health leaders should be *hoping* for an investment boom this year instead of *bracing* for one... One statistic jumped out at me: 46% are *still* working to achieve meaningful product-market fit. Doesn't seem to bode well for fundraising? Don't get me wrong - I'm hopeful that digital/virtual care options as part of the continuum of care can help people improve their health and finally start to bend the cost curve in healthcare. But a crowded market, with operating cash stretched and less purchasing activity suggest consolidation this year. Any investors care to weigh in? https://lnkd.in/gtG8uz6d

3

A thoughtful piece from The Wall Street Journal on a level of misdiagnosis to enhance the profits of payors in Medicare Advantage. For me, this article shines a light on a risk of AI and AI copilots in care, in functions including diagnosis to coding and billing. If the training data leads the utilized AI to maximize profit as a (not just the) driver, unintended margin not mission outcomes will win. Don't get me wrong, I believe in a relatively informed way that AI is the solution for our healthcare system. AI can solve for fraud, waste and abuse; it can produce more efficacious drugs and devices faster; it can enable clinicians to be even more accurate and maximize the time they can spend with patients (and in turn make the system overall more effective and profitable). But, as we race to implement, we must be mindful of the risk of training with less than absolutely perfect data sets. No luddite here, but mindful of the consequences. https://lnkd.in/gG-Hy_GK

20

John Kell's recent article in Fortune, "The best investment opportunities in AI for health care right now," provides incredible insights about the challenges of healthcare data and how it impacts the advancement of #ai. Three out of every four leading health care companies are experimenting with generative AI or attempting to scale it across their business. What are they creating and why? Venture capitalist Deena Shakir asks founders if they "are aiming to solve a technology problem or a clinical adoption problem". Solving existing problems will speed decision making and improve data quality. The Deloitte report:  “Navigating the Emergence of Generative AI in Health Care” shares some of the data challenge in health care. While boasting the largest source of raw data, 80% of the data are unstructured.  Simon Gisby, managing director and the global leader of life sciences and health care at Deloitte further expounds "But as an industry, we’re not surprisingly that good at analyzing and drawing correlations out of that" https://lnkd.in/gXE_HVG2 Read thus great article for use cases and examples from fertility and maternal health care to predicting adverse outcomes to drug development and immunotherapies. The future of health and #ai is the hope that we can provide value in health care data equal to the volume we produce Read the article here: https://lnkd.in/gTx6ic_b

11

Very interesting, insightful study. Flare Capital Partners AI in healthcare is hype. Most AI stories for healthcare are tech advancements. Not real clinical advancements or fitting into their workflows, bearing few. MedTech Innovators face these paradox. 1.Adoption requires Evidence. But evidence comes only from adoption. Clinical data can not be synthetic data for good AI. 2.Regulatory, validation requires money. But investors require regulatory, validation. 3.MedTech need faster adoption, but healthcare is slower among every profession, a cut-throat industry. They won't use it, if it is more than 2-3 mouse clicks. https://lnkd.in/gUh8sDHe

1

Health systems are considering monetizing patient data to support operations like drug discovery and precision medicine, but ethical concerns arise around patient consent and data commercialization. Leaders at a Becker’s Health IT conference emphasized the need for balance between innovation and patient privacy, with academic centers and startups at the forefront of leveraging data for medical advancements. Some advocate for patient-owned data and ethical frameworks to ensure responsible use.

1

Thrilled to announce at #CES2025 that Validic has added physical activity data from consumer wearables to the EHR clinical workflow! This innovation connects activity data from hundreds of wearables and smartwatches from Google, Fitbit, Apple, Samsung Electronics, Withings, ŌURA, Garmin and more into the EHR clinical workflow of Epic and Oracle Health. It’s of course built on our industry-leading health IOT platform, which already captures and delivers data from millions of people every single day. This means the devices available to clients are secure and will always be up-to-date with the latest in consumer wearables and health technologies. A few highlights: ⌚️350+ consumer wearables and smartwatches ✅ Automatic data capture and display in the EHR patient charts 🧑‍⚕️ Clincian workflow views of steps 👟, active minutes ⏱️, and calories burned 🔥 regardless of the manufacturer or device 🚀 Real-time connection and delivery, ensuring conversations with patients are based on the latest information 💡 Enables data-driven personalized care without disrupting existing clinical processes Shoutout to Amy McDonough from Google Health for providing insights and being an early advocate for lifestyle as a critical health indicator. Very proud of this effort from the Validic team and our digital health device partners! Read more here, including how increased physical activity is tied to meaningful health improvement for people living with most health conditions: https://lnkd.in/eEzVWEhP Jane Sarasohn-Kahn René Quashie Caroline Scott Bakul Patel Sandeep Pulim M.D. Jordan Bowlus Daniel Kraft, MD Keisuke Nakagawa, MD Antoine Robiliard David Strickland Ricky Y. Choi, MD, MPH Hon Pak Michael O'Reilly Steven Gipstein M.D. Kimberly Hutton, MD Leah Briggs

169

28 Comments

To meet CMS’ commitment to have all #Medicare beneficiaries in value-based payments (VBP) by 2030, payers have to dig deeper into #VBP design flaws and explore new strategies like: •Creating a coordinated set of VBP model designs to cut wasteful or inefficient spending without asking one participant to forgo all the revenue. •Introducing real savings requirements for shared savings, or implementing a risk-score growth cap to encourage better care practices. •Leaning into mandatory participation in new VBP programs to help ALL types of Medicare beneficiaries – not just larger-scale organizations. Read more about how these solutions can help accelerate VBP adoption in a recent Health Affairs article I wrote with Amol S Navathe and Daniel Shenfeld (linked in comments) #HealthcareonLinkedIn

21

1 Comment

Healthcare organizations must build AI solutions through a health equity lens from day one. Failing to do so places underserved communities at risk. To understand what's at stake, consider the harm caused by a biased equation for prioritizing kidney transplant patients. The test overestimated Black patients' kidney function, ranking them as healthier than non-Black patients. As a result, thousands of Black patients ended up farther down the transplant list than their conditions warranted — waiting years for the care they deserved. One woman who secured a spot on the list in 2019 discovered she should've earned her place in 2015, the Associated Press reported. You can read the full story here: https://lnkd.in/gdcF5h7d Today, efforts are underway to make up for the mistake. More than 14,000 Black people have had their wait time for a kidney transplant adjusted to address the bias. But healthcare can't stop there. We must seize this moment to commit to prioritizing health equity in AI solutions. Equations like the one used to evaluate kidney function already support countless care decisions for payers and providers. As AI solutions proliferate, the algorithms will only become more common and complicated. If organizations don't prioritize health equity in the AI development process, they risk building vast networks of solutions that actually harm communities. Once these solutions are in place, it may take years before experts can trace harmful practices back to lines of biased code. Building AI solutions is highly technical, but reducing bias requires a human touch. Including the voices, cultures, and lived experiences of diverse groups throughout development — from data gathering to deployment — will help ensure solutions respect everyone's needs. Assembling diverse teams to monitor AI once it's operational will help keep the technology from veering off course. Healthcare is poised to adopt AI in a big way. Oversight will determine whether they perpetuate past harms or create a healthier, more equitable future. #AI #HealthTechnology #HealthEquity #Healthcare

45

9 Comments

5 Things EscrowAI is Doing to Help Customers Meet the Coalition on Health AI’s (CHAI) Assurance Standards BeeKeeperAIis committed to helping healthcare organizations realize the Coalition for Health AI’s (@CHAI) Assurance Standards for effective, equitable, reliable, transparent, and secure AI/ML/Gen AI solutions. Due to our privacy and security safeguards integrated and automated into our privacy enhancing collaboration platform, EscrowAITM, we are enabling our customers to meet these essential standards in the following ways: 1. Enhancing Usefulness, Usability, and Efficacy EscrowAI ensures AI models are reliable, user-friendly, and improve healthcare workflows, while providing measurable benefits like better outcomes and efficiency. 2. Ensuring Fairness and Equity EscrowAI mitigates bias by securely enabling diverse data use, ensuring AI performs equitably across all patient groups, reducing disparities in healthcare. 3. Promoting Safety and Reliability EscrowAI continuously monitors AI systems to ensure they are safe, reliable, and capable of adapting to healthcare changes without failure. 4. Supporting Transparency and Accountability EscrowAI enables clear, interpretable AI decisions, allowing stakeholders to understand how models work and holding AI developers accountable. 5. Safeguarding Security and Privacy EscrowAI protects sensitive healthcare data throughout the AI lifecycle, ensuring privacy and security while complying with HIPAA and other regulations. Join us at the AI @ HLTH Pavilion, Booth 4611, on Tuesday, October 22nd, from 2-4 PM to learn how EscrowAI can help your organization meet CHAI’s Assurance Standards for trustworthy AI. Our team will be on hand to discuss how our solutions can enhance transparency, fairness, safety, and security while accelerating your time to market. Don’t miss this opportunity to explore how we can support your journey towards responsible healthcare AI!

32

#IngredientCosts in #prescriptiondrugs - what's the right metric? That's a great question. Let's review. 💊 AWP = I think we can all pretty much agree that AWP is a inaccurate metric for establishing actual acquisition costs of drugs. The joke in the industry is that it stands for "Ain't What's Paid." It's allegedly a markup of 20% on WAC or wholesale acquisition cost. Furthermore, generics can actually be discounted up to 98% the cost of AWP when all on and off invoice discounts and rebates are said and done. 💊 WAC = WAC might be a little better, maybe, at least on brand drugs. But not on generics. Percent off from wholesalers to pharmacies can be widely variable on generics as well. 💊 NADAC = (Full disclosure, I worked on the NADAC in the past.) NADAC is probably better than AWP and WAC, at least with Brands. Brands are usually with NADAC about WAC minus 1-6% (dependent upon class of trade of the pharmacy and/or their size). But again, generics are all over the place, and NADACs can vary widely to actual acquisition costs. There really isn't a great correlation between NADAC on generics and the actual drug price to the pharmacy. Not all pharmacies participate in NADAC, and NADAC pricing does not show off invoice rebates and discounts, so it's not the actual price the pharmacy paid either. Not all drugs have a NADAC, either. 💊 ASP = Average Sales Price. Not terrible, but only is for J code drugs or drugs that can be used in the medical benefit, put out quarterly by CMS. Doesn't really solve the problem of retail community practice actual drug costs for the pharmacy, after discounts, rebates, and all the other jazz. So, what's the BEST solution then? 💊 AAC = Actual Acquisition Cost. It clears out all the smoke and mirrors and clearly states what the pharmacy actually pays for the drug - this is really critical on both generics AND brands too - as reimbursements on brands by big 3 PBMs has been BELOW a pharmacy's actual acquisition cost, and this is what is driving over 2000 independent pharmacies out of business this year alone thus far. What do we use at Mark Cuban Cost Plus Drug Company, PBC? AAC. Yes, what we're showing you is actually what we actually paid for the drug. No off invoice rebates or discounts or any of that jazz. That and we make sure before we put a drug on our drug list that we have it available at our Actual Acquisition Cost to pharmacy team ups, both with Costplusdrugs.com as well as teamcubancard.com. No WAC, AWP or NADAC. Just what we paid, period. It's time to start using actual acquisition cost of drugs and get all the gobbleygook out of the way. (I'll save my opinion on drug rebates for another post and another day....) #pharmacy

13

7 Comments

Thank you for this comprehensive overview, Sam Pinson. The evolving landscape of AI governance in healthcare is critical for ensuring the ethical and effective deployment of AI solutions. Here are a few key takeaways and considerations: Regulatory Level Set 1. Data Stewardship: Compliance with HIPAA and FTC's Health Breach Notification Rule is essential for protecting patient health information (PHI). Ensuring robust data privacy and security measures is paramount for maintaining patient trust and regulatory compliance. 2. Consumer Protection: The recent FTC warning highlights the need for transparency in consumer privacy policies. AI developers must be vigilant in maintaining ethical data-sharing practices to avoid regulatory pitfalls. 3. Non-Discrimination: The new rule under Section 1557 of the ACA emphasizes the importance of mitigating risks related to AI and decision-support tools. Ensuring non-discriminatory practices in AI development and deployment is not only a regulatory requirement but also an ethical imperative. 4. Disclosures: The HTI-1 Final Rule from ONC underscores the necessity of comprehensive disclosure and risk management for predictive decision-support interventions (DSIs). Adherence to these regulations can provide a competitive edge for vendors integrating with certified EHR technology. 5. Medical Device Regulation: The FDA's regulation of software as a medical device (SaMD) remains a critical gatekeeping function. Navigating these pathways is essential for developers to ensure the safe and effective use of AI in clinical settings. 6. State Regulations: State-specific regulations, such as those in Colorado, Utah, and California, add another layer of complexity. Staying abreast of state-level requirements is crucial for comprehensive compliance. Best Practices and Compliance Developers and deployers should leverage industry roadmaps, federal agency guidelines, and emerging compliance structures to future-proof their AI governance strategies. The Executive Order 14110 and NIST Gen. AI Profile are valuable resources for developing robust governance frameworks. As we approach Q2, it will be important to continue monitoring regulatory developments and adapting governance strategies accordingly. Collaboration between industry stakeholders and regulatory bodies will be key to navigating this complex landscape and ensuring the responsible use of AI in healthcare. #AIgovernance #HealthTech #DataPrivacy #NonDiscrimination #Compliance #PatientSafety #Regulation

7

Unlocking Healthcare Interoperability: Overcoming EMR Barriers for Operational Excellence The healthcare industry is at a pivotal crossroads. Recent developments in EMR interoperability—such as the widespread adoption of the FHIR (Fast Healthcare Interoperability Resources) standards and the implementation of the 21st Century Cures Act's interoperability and information blocking rules—are setting the stage for a more connected and efficient healthcare ecosystem. However, significant roadblocks remain. Some of the largest EMR vendors have built proprietary systems that limit seamless data exchange. These closed platforms and lack of standardized APIs not only stifle innovation but also hinder healthcare providers from accessing comprehensive patient information. This fragmentation leads to increased administrative burdens and can adversely affect patient care. For healthcare tech-enabled service providers like #Neolytix, improving autonomous processing of operations is a core mission. Interoperability is not just a technical challenge for us—it's a fundamental requirement to enhance operational efficiency, reduce costs, and improve patient outcomes. Autonomous processing relies heavily on the ability to access and integrate data from various sources effortlessly. When data is siloed, the potential for automation and innovation is significantly diminished. The importance of breaking down these barriers cannot be overstated. By advocating for open standards and interoperability, we can: - Enhance Patient Care: Provide healthcare professionals with complete and accurate patient information, leading to better diagnosis and treatment. - Reduce Administrative Burdens: Streamline operations by automating routine tasks, allowing staff to focus more on patient care. - Foster Innovation: Enable new technologies and services to integrate seamlessly, driving the industry forward. At Neolytix, we're committed to navigating these challenges by leveraging cutting-edge technology and pushing for greater transparency and collaboration in the industry. We're working diligently to improve autonomous processing in healthcare operations, ensuring that the benefits of interoperability are fully realized. It's time for all stakeholders—EMR vendors, healthcare providers, policymakers, and tech innovators—to come together to overcome these obstacles. By doing so, we can unlock the full potential of healthcare interoperability and build a system that truly serves everyone's best interests. Join us in advocating for a more connected and efficient healthcare future. Let's work together to break down the barriers to interoperability and drive meaningful change in the industry. #HealthcareLeadership #HealthcareCFO #HealthcareCOO #HealthcareCEO #HealthcareOperations #HealthcareInteroperability #HealthTech #HealthcareInnovation #Neolytix

34

3 Comments

🌟 Generative AI and Healthcare Transformation: A New Era of Innovation 🌟 I am constantly asked about #AI applications for healthcare transformation. I continue to take people back to the pain points or problems being solved. The healthcare industry is undergoing a significant transformation, driven by the integration of generative AI. This revolutionary technology is currently reshaping the way we approach care management, early disease detection, and administrative tasks. Early Benefits of Generative AI: Enhanced Care Management: AI serves as a "co-pilot" for healthcare professionals, assisting in managing patient care more efficiently and accurately. This leads to improved patient outcomes and more personalized care plans. Early Disease Detection: AI's ability to analyze vast amounts of unstructured data enables early identification of diseases, potentially saving lives and reducing healthcare costs. It's a game-changer in preventive healthcare. Reducing Clinician Burnout: By automating repetitive administrative tasks, AI allows clinicians to focus more on patient care. This not only improves job satisfaction but also enhances the quality of care provided. Affordability and Efficiency: AI-driven processes streamline operations, making healthcare more affordable and accessible. From optimizing workflows to reducing operational costs, AI is paving the way for a more sustainable healthcare system. Challenges and Considerations: Ethical and Legal Frameworks: Ensuring AI is used responsibly requires robust ethical, legal, and policy frameworks. Trustworthy AI adoption is crucial for patient safety and health equity. Technology Infrastructure: Organizations need to update their technology infrastructure, including cloud capabilities, to fully support AI implementation. As we embrace these advancements, it's essential to stay informed and engaged in the conversation about how AI can continue to transform healthcare for the better. #HealthcareTransformation #GenerativeAI #HealthTech #Innovation #AIinHealthcare Thanks to sources McKinsey & Company (https://lnkd.in/g7HZHEST) and MedCity News (https://lnkd.in/gi95t4qJ)

8

1 Comment