Christina DiArcangelo’s Post

Article on CEO World Magazine: Navigating Healthcare Innovation and Regulation Under the Trump Administration by Christina DiArcangelo As President Donald Trump embarks on his second term, the healthcare industry is poised for significant shifts influenced by policy changes and technological advancements. For CEOs in the healthcare sector, understanding these developments is crucial for strategic planning and operational success. Regulatory Landscape and FDA Oversight The Trump administration has signaled a commitment to deregulation, aiming to streamline processes within federal agencies, including the Food and Drug Administration (FDA). This approach may expedite the approval pathways for medical devices and pharmaceuticals, fostering a more innovation-friendly environment. However, it also necessitates that companies maintain rigorous internal compliance standards to ensure product safety and efficacy in the absence of stringent regulatory oversight. Read the full article: https://lnkd.in/eBSpbr4q #trump #fda #healthcare #artificalintellgience #compliance #standards #safety #efficacy #planning #usa #unitedstates #article #ceo

21st Century Cures Act The 21st Century Cures Act, passed into law in the United States, addresses critical issues in healthcare, including interoperability challenges that arose during the rapid adoption of electronic health records (EHRs). Interoperability: The Cures Act aims to promote interoperability of healthcare information technology (IT) systems. It addresses concerns over data blocking, where healthcare IT vendors or providers intentionally impede the exchange or use of electronic health information (EHI). Medical Product Development: Beyond interoperability, the Cures Act also seeks to expedite medical product development and innovation, aiming to bring new therapies and treatments to patients more swiftly. Section 4003: This section of the Cures Act mandates interoperability requirements. It emphasizes the secure exchange of electronic health information among different health IT systems. The goal is to enable seamless access, exchange, and use of EHI without additional effort on the part of users. Data Blocking: The Act addresses practices that hinder the sharing of EHI, aiming to remove barriers that prevent healthcare providers and patients from accessing needed information for care coordination and decision-making. Patient Access: Patients are empowered under the Cures Act to access their electronic health information easily and securely, promoting patient engagement and involvement in their healthcare decisions. Health IT Standards: The Act promotes the use of health IT standards that support interoperability, such as HL7 and DICOM, ensuring that healthcare systems can communicate effectively across different platforms and settings. Regulatory Oversight: Regulatory bodies like the Office of the National Coordinator for Health Information Technology (ONC) oversee the implementation of Cures Act provisions, ensuring compliance and monitoring progress toward interoperability goals. Healthcare Transformation: By facilitating the exchange of health information, the Cures Act aims to improve care coordination, enhance patient safety, and support public health initiatives through better data analytics and research capabilities. https://lnkd.in/g5yEpwkv

In the competitive world of #digitalhealth, having innovative tech isn’t enough. To truly stand out, ventures must show #proven clinical evidence—and the key to achieving that? Strategic #partnerships. In our latest blog, we reveal: - How #clinicaltrials, #regulatory approvals, and peer-reviewed #studies can fast-track your #solution to market #success - Why #partnering with #biopharma is crucial for credibility and growth - How #ventures with validated #clinicalstrength are securing more #funding and accelerating #marketaccess Ready to see how evidence-based #innovation is shaping the future of digital health? 🚀 Read the full blog now and subscribe for exclusive access to our upcoming #report! Stay informed. Stay ahead. Together, let's shape the future of healthcare. 🌟 https://lnkd.in/dFMXGTjK

Emergo by UL shares a synopsis from MedCon 2024. We’ve organized our reporting based on topics related to pre-market and post-market. This Regulatory Insight was compiled by the manager of our US consulting portfolio, Sarah Fitzgerald. Topics discussed include, though not limited to: regulatory harmonization, digital health, Predetermined Change Control Plans, encouraging innovation, and de novos. Review the synopsis here: https://lnkd.in/gXwGKQtW . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #FDA #globaharmonization #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

A New Era in Patient Access to Innovation: The EU's New Health Technology Assessment Rules Have Arrived! 🌍💉 The European Union has officially introduced a transformative framework for Health Technology Assessment (HTA), marking a significant step forward in enhancing patient access to innovative therapies. These new regulations encourage greater collaboration and coordination between EU Member States, enabling quicker and more equitable access to cutting-edge medical treatments and technologies. 🚀 Key features of the new HTA framework include: 1. A Unified EU-Level Submission File: Developers will now submit a single, comprehensive file for joint clinical assessments, optimizing resources at the EU level and reducing unnecessary duplication across countries. 📄 2. Accelerated Assessments: Joint Clinical Assessments will be completed within 30 days of marketing authorization, streamlining the process for faster patient access. ⏱️ 3. Inclusion of Patient and Clinician Feedback: Regular consultations with patients and healthcare professionals will ensure that real-world insights are incorporated into the evaluations. 👩⚕️👨⚕️ Phased Rollout: 4. Effective from January 12, 2025, the new rules will apply to marketing authorization applications for new cancer treatments and advanced therapy medicinal products (ATMPs). 🧬 5. By 2028, these rules will expand to include orphan medicines, and by 2030, all new medicinal products will be included. High-risk medical devices will be covered starting in 2026. ⚙️ This new framework replaces the previous project-based cooperation between Member States, reinforcing their autonomy in healthcare management while enhancing the scientific rigor of HTA processes across the EU. 🇪🇺 This initiative marks a pivotal shift for patients, paving the way for quicker access to life-saving therapies and supporting innovation and efficiency for health technology developers. 💪💊 #HealthcareInnovation #HealthTechnology #EURegulation #PatientAccess #HTA #EuropeanUnion #IMDR #21CFR #USFDA

The global regulatory policy landscape for real-world data (RWD) and real-world evidence (RWE) is crucial for ensuring the quality, reliability, and validity of these data sources in healthcare decision-making. 1. Standardization and harmonization: Global regulatory policies help to establish standardized guidelines and requirements for the collection, analysis, and reporting of RWD/RWE. This promotes consistency and comparability across different regions and healthcare systems, making it easier to aggregate and interpret data from multiple sources. 2. Quality assurance: Regulatory policies set standards for data quality, integrity, and reliability, ensuring that RWD/RWE are collected and analyzed in a rigorous and transparent manner. This helps to minimize bias, errors, and inconsistencies in the data, leading to more accurate and reliable evidence for decision-making. 3. Ethical considerations: Regulatory policies help to address ethical and privacy concerns related to the use of RWD/RWE, such as data protection, informed consent, and patient confidentiality. By establishing clear guidelines and safeguards, regulatory policies help to protect the rights and interests of patients and ensure that data are used responsibly and ethically. 4. Regulatory acceptance: A well-defined regulatory policy landscape can facilitate the acceptance and recognition of RWD/RWE by regulatory agencies, payers, and other stakeholders. This can help to streamline the approval process for new drugs, devices, and treatments, and support the use of RWD/RWE in regulatory decision-making and health technology assessments. 5. Innovation and collaboration: Regulatory policies that support the use of RWD/RWE can encourage innovation in healthcare research and delivery, by enabling the use of real-world data to generate new insights, identify trends, and evaluate the effectiveness of interventions. This can also foster collaboration among researchers, healthcare providers, industry partners, and regulatory agencies, leading to more efficient and effective healthcare solutions. A strong global regulatory policy landscape for RWD/RWE is essential for ensuring the credibility, validity, and utility of real-world data in healthcare decision-making. By establishing clear guidelines, standards, and safeguards, regulatory policies can help to promote the use of RWD/RWE as valuable sources of evidence for improving patient outcomes, advancing medical research, and driving innovation in healthcare.

📊 Today’s Pharmacovigilance: Data Gaps Impacting Health Outcomes and Costs 📊 Pharmacovigilance today relies heavily on clinical trials, EMRs, and pharmacy records. While these are foundational, they often fall short in key areas: 💥Lack of Diversity 🌎: Clinical trials traditionally underrepresent diverse populations, which limits our understanding of how medications perform across demographic groups. Despite recent FDA initiatives to improve diversity in clinical trials, these efforts don’t address the broader data limitations pharmacovigilance teams face. The narrow scope of traditional data sources leaves many gaps, making it difficult to ensure safety and efficacy across all populations. 💥Narrow Scope of Traditional Data Sources 🔍: EMRs and pharmacy records primarily capture information during doctor visits or hospital stays, representing only a small fraction of daily life. This limited scope contributes to adverse drug events (ADEs), which lead to nearly 5% of hospitalizations and add approximately $30 billion annually to U.S. healthcare costs (AHRQ). 💥Barriers to Trial Participation 🚧: Research shows that individuals in underserved communities are often more willing to share data through health apps and wearables than participate in trials, due to accessibility, trust, and time barriers. Consumer-generated Real-World Evidence (RWE) captures everyday health insights, offering valuable data on safety and effectiveness for populations traditionally left out of trials. With Adverse Drug Reactions 💊 ranking among the top causes of hospitalizations, consumer RWE could offer the comprehensive, real-world insights needed to prevent ADEs, reduce healthcare costs, and ensure medications are safe and effective for all. As the global healthcare landscape shifts towards greater health equity, consumer RWE represents a critical step toward an inclusive, effective pharmacovigilance approach that leads to better, more personalized care. 🔗 Learn more: https://lnkd.in/d9J54v6v #Pharmacovigilance #HealthEquity #RealWorldEvidence #DiversityInHealth #FDA #ConsumerHealth #HealthTech #PatientSafety #ClinicalTrials #DigitalHealth #KnowRX #RWE #HealthcareInnovation #CHR #PIXS

𝐒𝐨𝐦𝐞 𝐃𝐞𝐧𝐭𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐨𝐟𝐭𝐞𝐧 𝐝𝐞𝐜𝐢𝐝𝐞 𝐨𝐧 𝐜𝐨𝐧𝐝𝐮𝐜𝐭𝐢𝐧𝐠 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐢𝐞𝐬 𝐛𝐚𝐬𝐞𝐝 𝐬𝐨𝐥𝐞𝐥𝐲 𝐨𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬. 𝐓𝐡𝐚𝐭’𝐬 𝐫𝐢𝐬𝐤𝐲. Startups typically rely on regulations to decide if a study is “needed,” while larger companies conduct multiple studies to build trust and prove effectiveness to end users. From a start-up's perspective, clinical studies are expensive and funds need to be raised to conduct them. Fair enough. 𝐁𝐮𝐭 𝐰𝐡𝐚𝐭 𝐢𝐟 𝐈 𝐭𝐨𝐥𝐝 𝐲𝐨𝐮 𝐭𝐡𝐚𝐭 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬, 𝐫𝐞𝐠𝐚𝐫𝐝𝐥𝐞𝐬𝐬 𝐨𝐟 𝐬𝐢𝐳𝐞, 𝐜𝐚𝐧 𝐩𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥𝐥𝐲 𝐬𝐚𝐯𝐞 𝐦𝐢𝐥𝐥𝐢𝐨𝐧𝐬 𝐢𝐟 𝐭𝐡𝐞𝐲 𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐞 𝐒𝐌𝐀𝐑𝐓 𝐝𝐚𝐭𝐚 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐰𝐞𝐥𝐥-𝐝𝐞𝐬𝐢𝐠𝐧𝐞𝐝 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬? I often wear 2 hats to support my clients and my clinical community best. 🥼 If I wear my clinician's hat, I'll look for robust clinical data to guide my treatment decisions on new products that I wish to try out at my clinic. I need a group of well-conducted studies, plus peer opinion, to take this decision 👩💼 Whilst, if I wear my MedTech consultant's hat, I see why startups err on their clinical, regulatory and marketing strategies, often getting rude awakenings along their product's development journey, from regulatory bodies or end users. But regardless of company size, clinical studies can be optimized to save millions while meeting regulatory and marketing needs. Here’s how I help my clients: ✔️𝐈𝐒𝐎 𝟏𝟒𝟏𝟓𝟓-𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭 𝐒𝐭𝐮𝐝𝐢𝐞𝐬: Designed to meet global regulatory standards, avoiding the need for multiple regional studies. ✔️ 𝐃𝐮𝐚𝐥-𝐏𝐮𝐫𝐩𝐨𝐬𝐞 𝐃𝐚𝐭𝐚: A single study generates data for both regulatory approval and marketing materials, reducing hurdles for both teams. I ensure that studies are designed to balance the best interests of Principal Investigators (PIs) and the company. I win when both sides WIN. So if you’re planning a clinical study or need an SME to review your protocol, then DM me. 𝐋𝐞𝐭’𝐬 𝐦𝐚𝐤𝐞 𝐲𝐨𝐮𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐚𝐭𝐚 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐭, 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞, 𝐠𝐥𝐨𝐛𝐚𝐥𝐥𝐲 𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 & 𝐫𝐞𝐮𝐬𝐚𝐛𝐥𝐞.

Exciting news in the world of Digital Health & Therapeutics. The FDA's Digital Center of Excellence has released their December 2024 Report, providing crucial guidance. Why is this important? Digital health and therapeutics are set to revolutionize healthcare by seamlessly integrating health into the patient's everyday life. Imagine healthcare that meets you where you are, in the normal flow of your daily routine. This transformation is not just about convenience; it's about enhancing patient outcomes and making healthcare more accessible and personalized. Making health more "you." The report highlights five key medical software functions that are excluded from the device definition by the 21st Century Cures Act: - Administrative Support of a Healthcare Facility - Maintaining or Encouraging a Healthy Lifestyle - Electronic Patient Records - Transferring, Storing, Converting Formats, or Displaying Clinical Laboratory Test or Other Device Data and Results - Certain Clinical Decision Support It's an amazing time to be at Intermountain Health, where we are excited to be at the forefront of this transformation. We are actively refining our digital formulary to integrate these advancements, ensuring that our patients receive the best possible care in their everyday lives. It's a delight to craft our Digital Health strategy with Golden Lyle Flint, Kacey Crandall, Pallavi Ranade-Kharkar, PhD, MS, FAMIA and Mona Baset, MBA, MA, CHCIO, CDH-E. Don't miss the "Best Practices" and "Changes or additions since last published report" sections – they are packed with high-yield insights. This is a must-read for developing a Digital Health strategy in today's dynamic landscape. #DigitalHealth #Therapeutics #HealthcareInnovation #PatientCare #FDA #HealthTech #MedicalSoftware #HealthcareTransformation