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In today’s healthtech in a nutshell:

Interoperability at a Crossroads: Carequality's Landmark Ruling on Epic and Particle Health

The summary:

Carequality, a nonprofit network facilitating nationwide health data exchange, has concluded its investigation into a dispute between Epic, a major electronic health record provider, and Particle Health, a health data platform. Centered on access to patients' health data and its use, Carequality released a 25-page redacted resolution aimed at settling this internal conflict. For more on Particle and Epic’s ongoing legal dispute, check out our previous newsletter!

Key points:

• Corrective Actions for Particle Health: Particle must demonstrate thorough adherence to Carequality's processes, including improved onboarding diligence for customers. Moreso, two of Particle Health's customers were found to have submitted data requests not intended for treatment purposes and are now prohibited from participating in Carequality for 12 months.

• Validation of Epic's Data Exchange Decisions: Epic's choice to not exchange data with certain Particle Health customers was deemed generally permissible under Carequality's framework. The resolution supports Epic's stance that some of Particle Health's customers inappropriately accessed medical records by falsely claiming to be treating patients.

• Policy Updates and Transparency Requirements for Epic: Epic must update its policies to include clear, objective criteria for determining if an organization is performing treatment. These updates are required to provide information confirming compliance for the next six months. This aims to increase transparency and clarity in Epic's decision-making process regarding data exchange.

Why this matters:

This resolution highlights the need for clearer definitions and guidelines around data access and use, particularly regarding what constitutes "treatment" purposes. It also demonstrates that there is a need for improved oversight and governance in health data exchange networks to prevent misuse of sensitive patient information.

ShiraTronics to Launch Non-Invasive Migraine Treatment After $66 Million Funding Round

The summary:

ShiraTronics has raised $66 million in funding to advance its innovative treatment for chronic migraines, leveraging neuromodulation technology. This device aims to provide a non-invasive solution for the millions suffering from chronic migraines, addressing a significant unmet need in migraine management. The funding will be used for clinical trials and regulatory processes to bring the treatment to market.

Key points:

• Innovative Neuromodulation Technology: ShiraTronics' device uses neuromodulation to alter nerve activity through targeted electrical stimulation. This approach differs from traditional medication therapies, which can have limited efficacy and side effects. The goal is to reduce both the frequency and severity of migraine attacks in patients.

• Funding Utilization: The $66 million raised will primarily support clinical trials, necessary for demonstrating the safety and effectiveness of the device. This funding is crucial for navigating the regulatory approval process, which is essential for market entry.

• Market Need and Context: Chronic migraines affect about 12% of the global population, highlighting a critical public health issue. Current treatments often fall short, leading to a strong demand for new solutions. ShiraTronics aims to fill this gap, potentially improving the quality of life for countless individuals suffering from this condition.

Why this matters:

The advancement of ShiraTronics represents a potential breakthrough in managing chronic migraines, an area with limited effective options. By focusing on non-invasive solutions, the company may not only improve patient outcomes but also pave the way for broader acceptance of neuromodulation therapies in treating various neurological conditions. This innovation could inspire further research and development in the field, ultimately contributing to a more effective healthcare landscape for chronic pain management.

Microsoft's Healthcare AI Trifecta: New Models, Data Solutions, and Workflow Enhancements

The summary:

Microsoft has introduced new AI-powered tools and capabilities for healthcare organizations through Azure AI Studio and Microsoft Fabric. These tools aim to improve patient care, support healthcare workers, and enhance data management and analysis in the healthcare sector. The new offerings include AI models developed with partners like Providence and Paige.ai.

Key points:

• New AI models in Azure AI Studio: Microsoft has developed AI models with healthcare partners Providence and Paige.ai for Azure AI Studio. These models enable healthcare organizations to integrate and analyze diverse data types, build and deploy AI solutions for specific needs with minimal resources. These are useful in pathology and medical imaging driving advancements in cancer research and diagnostics.

• Healthcare Data Solutions in Microsoft Fabric: Microsoft Fabric offers a unified AI-powered platform that transforms how users access, manage, and act on healthcare data. New capabilities in public preview include conversational data integration, social determinants of health dataset transformation, care management analytics, and data discovery and cohorting.

• AI-powered Workflow Improvements: Microsoft's new tools focus on streamlining administrative tasks, particularly for nurses, using AI-powered ambient voice technology to populate patient assessments. These solutions aim to reduce clinician burnout by automating tedious tasks, allowing healthcare professionals to spend more time on direct patient care.

Why this matters:

This addresses critical challenges in healthcare including data management and integration, clinician burnout, advancing medical research, and improving the quality of patient care. By providing tools to better manage and analyze healthcare data, organizations can gain a more comprehensive view of patient experiences and make more informed decisions while also streamlining/automating workflows or admin tasks.

OTrending Sectors in Digital Health x AI:

Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share with us their industry insights on what’s trending in the space. With digital health AI technologies so vastly transforming drug development and healthcare delivery, Sidley’s opinion report highlights the 5 key trends in the European life sciences industry. Take a look!

1. MedTech and Digital Health Rise Along with Regulations in the space

   • The European MedTech market is thriving, valued at approximately €160 billion in 2023, with digital health expected to grow at 9.30% annually, driven by digital treatment adoption. Regulations like the Medical Devices and AI Act have not hindered this growth.

2. Cybersecurity Developments

   • Investors demand robust cyber risk management from digital health firms. Companies are increasingly innovative in addressing evolving cybersecurity threats to safeguard their operations and customer data.

3. Expansion of Pathways for Market Access

   • European countries are enhancing access to digital health applications through initiatives like Germany’s DiGA for reimbursable health apps and France's reimbursement for remote consultations, fostering a more accessible digital healthcare environment.

4. The Turn Towards FemTech

   • With the FemTech market projected to reach a US$1 trillion opportunity by 2040, only 3% of digital health investments currently target this sector. Increasing focus on women’s health, including areas like HPV vaccines and chronic disease management, highlights substantial growth potential.

5. Government-Backed Hubs focused on Digital Health

   • European governments are funding MedTech startups through initiatives like the UK’s National Institute for Health and Care Research and Spain’s Digital Health Strategy, providing resources like funding and mentorship to support digital health innovations.

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