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Highlights & Summary
Q2 2024 has seen substantial advancements in the digital health and informatics sectors, marked by significant policy developments, innovative product launches, and strategic partnerships.
A bipartisan Senate AI working group has released a comprehensive roadmap to foster AI research and development in healthcare, emphasizing the importance of safety guardrails and regulatory support from agencies like the NIH, FDA, and ONC. This initiative underscores a growing commitment to integrating AI technologies safely and effectively into healthcare systems to improve patient outcomes. Additionally, the WHO introduced S.A.R.A.H. (Smart AI Resource Assistant for Health), an AI-driven digital health promoter designed to provide around-the-clock health information in multiple languages and guidance on managing risk factors for prevalent conditions such as cancer and heart disease. NIH researchers also developed an AI tool capable of predicting cancer patients' responses to specific treatments by analyzing single-cell RNA sequencing data.
The AI / imaging space saw FDA approvals and M&A activity, in addition to exciting partnerships such as Open.AI and Color Health’s partnership to improve patient care efficiencies. Disease Management / Digital Therapeutics saw new FDA approvals, with Apple Watch scoring clearance for use of its AFib History feature in clinical trials to estimate a study participant’s weekly AFib burden.
In Women’s Health / Femtech, new product launches, regulatory approvals, and acquisitions spanned maternal health, midlife health, and more. Finally, the Informatics / Healthcare IT Solutions segment experienced notable growth. Aegis Ventures launched a Digital Consortium in partnership with nine leading health systems to co-develop and deploy advanced health tech solutions addressing challenges like health equity and clinician burnout. Google’s Med-Gemini AI models have demonstrated superior performance in clinical reasoning and multimodal understanding, highlighting the transformative potential of AI in healthcare informatics.
These developments, alongside strategic acquisitions and partnerships, signal a robust and innovative future for digital health and informatics, with technology playing an increasingly vital role in enhancing healthcare delivery and patient care.
Overarching Industry Updates
2 | WHO Unveils a Digital Health Promoter Harnessing Generative AI for Public Health
3 | NIH Researchers Develop AI Tool Toward More Targeted Cancer Treatment
4 | AMA Weighing Substantial Expansion of Remote Patient Monitoring Codes
AI / Imaging
1 | FDA Clears Eko Health’s AI for Early Detection of Low Ejection Fraction in Heart Failure
2 | Philips Future Health Index 2024 Report Highlights AI as Key to Addressing Healthcare Gaps
3 | CARPL.ai Receives FDA Clearance to Enhance Safety in Clinical AI Deployment
4 | OpenAI and Color Health Partner to Transform Cancer Care with AI-Powered Copilot
5 | Race and Ethnicity Characteristics Impact AI Performance in Breast Cancer Screening
6 | GE Healthcare Completes MIM Software Acquisition to Boost Precision Care Strategy
Disease Management / Digital Therapeutics
1 | The FDA Approves Apple Watch’s Atrial Fibrillation History Feature for Use in Clinical Trials
3 | Uber Health Announces Uber Caregiver to Enable Caregiver Support for its Members
4 | Walmart Announces Closing of its Health Centers and Clinics
5 | Mayo Clinic Partners with Zipline to Make Deliveries Directly to Patients’ Homes
Informatics / Healthcare IT Solutions
1 | Google's Med-Gemini Models Claim to Surpass State-of-the-Art Clinical Tools
2 | Aegis Ventures Launches Digital Consortium with Nine Leading Health Systems
3 | Veterans Health Administration Launches Digital Health Office to Streamline Tech Initiatives
4 | Epic vs. Particle Health Dispute Highlights Challenges in Health Data Exchange
5 | Praia Health Partners with CLEAR to Enhance Healthcare Identity Verification
Women’s Health / Femtech
3 | IVF 2.0 Revolutionizes Fertility Assessment with Launch of SiD 2.0
4 | Siemens Healthineers Receives FDA 510(k) Clearance for MAMMOMAT B.brilliant Mammography System
5 | Midi Health Accelerates Mission, Closing $60M Series B Round Led by Emerson Collective
Overarching Industry Updates
A bipartisan senate AI working group released a roadmap for AI policy in the U.S. Senate, encouraging funding for cross-government artificial intelligence research and development projects for medicine and healthcare. The policy advocates for the establishment of appropriate guardrails and transparency to ensure that technology that is being developed is ultimately safe for patients. The policy also urges support for the NIH, FDA, and Office of the National Coordinator for Health Information technology to ensure that they have the tools to regulate and assess the benefits vs risks of AI products.
2 | WHO Unveils a Digital Health Promoter Harnessing Generative AI for Public Health
The World Health Organization (WHO) announces the launch of S.A.R.A.H., a pioneering digital health promoter prototype, coinciding with World Health Day's theme, 'My Health, My Right'. S.A.R.A.H. (Smart AI Resource Assistant for Health) embodies a significant advancement in AI-driven health information avatars, boasting enhanced empathetic capabilities facilitated by generative artificial intelligence (AI). This innovative platform is designed to engage users around the clock, across eight languages, and on various health topics, utilizing cutting-edge technology accessible on any device. With a focus on empowering individuals to optimize their health and well-being journey, S.A.R.A.H. offers support in understanding risk factors associated with prevalent health conditions like cancer, heart disease, and diabetes, while promoting healthy habits and mental wellness. WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasizes the role of digital technologies in advancing global health, calling for ongoing research to explore the potential benefits and address ethical considerations surrounding AI integration in public health initiatives.
3 | NIH Researchers Develop AI Tool Toward More Targeted Cancer Treatment
NCI researchers have introduced a new artificial intelligence (AI) tool capable of leveraging individual cell data within tumors to forecast a cancer patient's response to specific drugs. Published in Nature Cancer, this innovation aims to aid physicians to precisely match cancer patients with drugs tailored to their specific cancer type. Unlike conventional methods reliant on bulk sequencing of tumor DNA and RNA, this AI model integrates single-cell RNA sequencing data, offering heightened resolution down to the individual cell level. By honing in on distinct clones within tumors, researchers anticipate more enduring drug responses, seeking to impact cancer treatment strategies. The study demonstrated the AI's efficacy across various cancer types and treatment scenarios, highlighting its potential to inform personalized treatment plans. To facilitate broader application, researchers have developed a website and guide for implementing the AI model, known as Personalized Single-Cell Expression-based Planning for Treatments In Oncology (PERCEPTION), with new datasets.
4 | AMA Weighing Substantial Expansion of Remote Patient Monitoring Codes
The American Medical Association (AMA) discussed anticipated CPT code changes during the second quarter 2024 CPT Editorial Panel meeting. Remote care provider Prevounce discussed the potential impact of this meeting, particularly the focus on expanding remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) CPT codes. Proposed actions include adding new codes for remote patient monitoring device supplies, revising existing codes to accommodate shorter durations and communication times, and introducing multiple codes for remote therapeutic monitoring. While Medicare is not obligated to adopt these changes, it typically follows AMA's lead, potentially impacting coding and billing practices for RPM and RTM services starting in 2025. Despite initial considerations for a full redesign of RPM codes, AMA's current proposal reflects a pivot towards refining existing codes, prompting providers to prepare for potential coding and billing adjustments to align with updated regulations and maximize program performance.
AI / Imaging
1 | FDA Clears Eko Health’s AI for Early Detection of Low Ejection Fraction in Heart Failure
Eko Health has received FDA clearance for its AI-powered Low Ejection Fraction (Low EF) detection tool, developed in collaboration with Mayo Clinic. This AI integrates with Eko’s digital stethoscopes, enabling healthcare professionals to detect heart failure during routine check-ups in just 15 seconds. This innovation aims to improve early diagnosis and treatment, particularly in primary care settings, and addresses significant gaps in heart failure detection. The Low EF AI is part of Eko’s SENSORA™ Cardiac Early Detection Platform, which aims to better patient outcomes and streamline healthcare delivery.
2 | Philips Future Health Index 2024 Report Highlights AI as Key to Addressing Healthcare Gaps
The 2024 Future Health Index report by Philips highlights how healthcare leaders are increasingly turning to AI to tackle critical gaps in patient care, especially amid staff shortages and rising demand. The report reveals that 92% of leaders believe technology can alleviate staff burden through automation, although skepticism remains among healthcare professionals. Virtual care and AI-driven innovations are seen as essential for enhancing efficiency, reducing wait times, and improving patient outcomes. The study underscores the need for inclusive AI adoption in healthcare to achieve widespread improvements.
3 | CARPL.ai Receives FDA Clearance to Enhance Safety in Clinical AI Deployment
CARPL.ai has obtained FDA 510(k) clearance for its AI platform, designed to streamline and secure the deployment of clinical AI in radiology. The platform features a universal AI viewer that integrates with major PACS systems, allowing radiologists to utilize multiple AI applications through a single interface. This clearance underscores CARPL.ai's commitment to enhancing patient safety and operational efficiency in radiology workflows. CARPL.ai specializes in providing innovative AI solutions to improve diagnostic accuracy and patient care in medical imaging, ensuring reliable and effective use of AI in clinical settings.
4 | OpenAI and Color Health Partner to Transform Cancer Care with AI-Powered Copilot
Color Health has partnered with OpenAI to develop an AI-powered copilot application aimed at accelerating cancer diagnosis and treatment. Using OpenAI’s GPT-4o, the tool helps clinicians identify missing diagnostics and create tailored treatment plans, improving patient care efficiency and outcomes. The copilot integrates patient data with clinical guidelines, allowing healthcare providers to make evidence-based decisions quickly. This collaboration aims to address access to personalized cancer care while maintaining patient safety and privacy, ultimately transforming the landscape of oncology treatment.
5 | Race and Ethnicity Characteristics Impact AI Performance in Breast Cancer Screening
A study from Duke University explores how patient demographics influence the accuracy of the FDA-approved AI algorithm ProFound AI in interpreting negative digital breast tomosynthesis (DBT) screenings. The research found that Black patients and older individuals had higher false-positive rates, while Asian patients had lower rates. The study emphasizes the need for diverse training data and transparent AI development processes to ensure equitable healthcare outcomes, highlighting the potential for improved diagnostic performance across varied patient populations.
6 | GE Healthcare Completes MIM Software Acquisition to Boost Precision Care Strategy
GE Healthcare has successfully acquired MIM Software, enhancing its portfolio and advancing its precision care strategy. This acquisition aims to integrate MIM Software's advanced imaging and workflow solutions into GE Healthcare's existing systems, thereby improving diagnostic accuracy and patient outcomes. The move is part of GE Healthcare's ongoing expansion of precision health capabilities and innovative solutions to healthcare providers. This acquisition will enable more personalized and precise care across various medical imaging applications, furthering GE Healthcare's position in the healthcare technology sector.
Disease Management / Digital Therapeutics
1 | The FDA Approves Apple Watch’s Atrial Fibrillation History Feature for use in Clinical Trials
The U.S. FDA announced that the Apple Atrial Fibrillation (AFib) History Feature now qualifies as a Medical Device Development Tool (MDDT) to assess AFib burden estimates within clinical studies and trials. Apple’s AFib feature is the first digital health technology to qualify under FDA’s MDDT program, which is aimed to help improve predictability and efficiency in device development and regulatory review. The FDA states that the AFib Feature can be used in clinical trials to estimate a study participant’s weekly AFib burden and as a secondary effectiveness endpoint within clinical studies to evaluate the safety and effectiveness of cardiac ablation devices.
The FDA clears for marketing Otsuka Pharmaceutical’s Rejoyn, a precision digital therapeutic app for the treatment of Major Depressive Disorder (MDD) to support clinician-managed care for adults 22 and older who are on antidepressant medication. The app provides interactive behavioral interventional therapy, including cognitive behavioral therapy lessons and emotional training exercises for the brain. Rejoyn will be available for download in the App Store and Google Play store in summer 2024.
3 | Uber Health Announces Uber Caregiver to Enable Caregiver Support for its Members
Uber Health has announced its Uber Caregiver program, which allows users to add a caregiver to their profile to ask for rides and deliveries while allowing their loved ones to track them in real time. Uber Health states that some pre-paid health benefit plans can cover eligible expenses and be used towards grocery and over-the-counter deliveries as well as non-emergency medical transportation. Uber Health plans to form partnerships with Medicare, Medicaid, and commercial plans to further provide benefits for its members within this program.
4 | Walmart Announces Closing of its Health Centers and Clinics
After launching Walmart Health in 2019, Walmart announces that they are closing Walmart Health and Walmart Health Virtual Care as they determined it was not a sustainable business to continue running given a challenging reimbursement environment and growing operating costs. The decision will close all 51 health centers across 5 states but Walmart will continue operating their 4,600 pharmacies and 3,000 vision centers. Walmart notes the growing importance of pharmacies as they expand the services their centers provide including immunizations, testing and treatment services, and a variety of health screenings.
5 | Mayo Clinic Partners with Zipline to Make Deliveries Directly to Patients’ Homes
Zipline announces a partnership with Mayo Clinic to service their Platform 2 to Mayo Clinic’s campuses in Jacksonville, Florida and Rochester, Minnesota. Mayo Clinic will use Zipline’s autonomous drones to make deliveries to their patients’ homes; deliveries include medications and supplies from the hospital to a person’s home within minutes. The Zipline Platform 2 is an autonomous delivery drone that can travel 10 miles in 10 minutes and is expected to reach patients in 11 states and service more than 30 million people in the United States. Combined with Mayo Clinic, a leading academic institution with an innovative hospital-at-home program, this partnership will explore new frontiers in the way healthcare can be delivered to patients.
Informatics / Healthcare IT Solutions
1 | Google's Med-Gemini Models Claim to Surpass State-of-the-Art Clinical Tools
In an open-source paper, Google asserts that its Med-Gemini AI models, based on Gemini 1.0 and 1.5, outperform existing clinical tools in the informatics and healthcare IT solutions space. Discussing advancements in clinical reasoning and multimodal understanding, Med-Gemini models achieved 91.1% accuracy on the MedQA (USMLE) benchmark, surpassing GPT-4 and performing in tasks such as medical note summarization and referral letter generation. These models highlight substantial improvements in healthcare informatics, promising enhanced efficiency and accuracy in clinical settings.
2 | Aegis Ventures Launches Digital Consortium with Nine Leading Health Systems
Aegis Ventures has established a Digital Consortium in collaboration with nine top health systems, including Stanford Health Care, Northwell Health, and Ochsner Health, to revolutionize informatics and healthcare IT solutions. This consortium focuses on co-developing, investing in, and deploying advanced health tech solutions addressing issues such as health equity, digital access, and clinician burnout. Leveraging over $65 billion in combined operating revenue, the founding members will benefit from Aegis' financial backing and expertise to rapidly create and implement innovative prototypes tailored to their specific needs. The consortium aims to enhance patient outcomes, reduce healthcare costs, and streamline operations by fostering a collaborative environment where health systems can share insights and develop scalable IT solutions. Aegis Ventures will support these efforts through strategic investments and resources, ensuring that the technologies developed are effective and widely adoptable across various healthcare settings. This partnership is expected to drive significant advancements in healthcare delivery, making cutting-edge technology more accessible and beneficial to both providers and patients.
3 | Veterans Health Administration Launches Digital Health Office to Streamline Tech Initiatives
The Department of Veterans Affairs’ Veterans Health Administration (VHA) has established a new Digital Health Office (DHO) to centralize its technology-focused components. Launched on June 2, 2024, the DHO consolidates VHA's offices of connected care, population health, health informatics, strategic initiatives lab, and artificial intelligence programs. With 600 personnel, the DHO aims to enhance digital health strategy and execution, fostering partnerships to develop and implement digital innovations across VA facilities. The DHO is in its early stages but seeks to optimize VHA’s digital health resources for better clinician and patient experiences.
4 | Epic vs. Particle Health Dispute Highlights Challenges in Health Data Exchange
The ongoing dispute between Epic and Particle Health reveals critical challenges in the healthcare data exchange ecosystem. Epic ceased data requests from some Particle Health customers due to concerns about the improper disclosure of protected health information, potentially violating HIPAA regulations. This decision impacts millions of patient encounters annually, with Particle Health asserting that Epic's actions are against established data sharing rules designed to prevent such disruptions. Despite the contention, the majority of Particle Health's clients continue to receive data from Epic. Both companies are engaged in discussions to resolve the issue, emphasizing the need for better transparency and trust in health data exchanges. This conflict underscores the broader need for clearer guidelines and improved gatekeeping practices to ensure secure, compliant, and efficient data sharing across healthcare networks.
5 | Praia Health Partners with CLEAR to Enhance Healthcare Identity Verification
Praia Health has announced a strategic partnership with CLEAR to enhance identity verification processes within healthcare systems. By integrating CLEAR's biometric authentication technology with Praia Health's digital health platform, this collaboration aims to streamline user verification, enabling more secure and personalized patient engagements. This partnership is expected to improve operational efficiency and data security across healthcare networks. Community Health Network in Indianapolis will be the first to implement this solution. Praia Health, known for its innovative healthcare solutions, is poised to set new standards in patient identity management. The implications of this partnership extend to improved patient care, reduced administrative burdens, and enhanced trust in digital health services, marking advancement in the field of healthcare technology.
Women’s Health / Femtech
Samsung Medison, a global medical equipment company, has announced its acquisition of Sonio SAS, a fetal ultrasound AI software company, aiming to enhance its position in the medical device market. Sonio, established in 2020, specializes in AI solutions for obstetrics and gynecology ultrasound exams, offering FDA-cleared AI assistants to improve image quality and clinical accuracy in real time. Following the acquisition, Sonio will continue to operate independently while collaborating with Samsung to advance AI-enhanced prenatal care.
Curio Digital Therapeutics has received FDA clearance for MamaLift Plus, an eight-week prescription digital therapeutic designed for postpartum depression (PPD) treatment. The clearance follows the successful results of the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) study, demonstrating efficacy in improving EPDS (Edinburgh Postnatal Depression Scale) scores. MamaLift Plus offers cognitive behavioral therapy, behavioral activation therapy, interpersonal therapy, and dialectical behavior therapy for PPD, providing a non-pharmaceutical alternative for women seeking relief from postpartum depression symptoms. Driven by the shortage of mental health professionals, MamaLift Plus's clearance marks advancement in addressing the unmet needs of women experiencing PPD.
3 | IVF 2.0 Revolutionizes Fertility Assessment with Launch of SiD 2.0
IVF 2.0 has unveiled SiD 2.0, an advanced upgrade to its sperm assessment software, integrating powerful improvements like an enhanced scoring algorithm, innovative object identification tool, and robust reporting features. This AI-driven software revolutionizes sperm evaluation, addressing the subjective nature of traditional selection methods used by clinical embryologists, providing data-driven assistance for more informed decisions. Designed to complement embryologists' expertise, SiD 2.0 aims to enhance transparency and clinical outcomes in fertility clinics worldwide, reflecting IVF 2.0's commitment to innovation in reproductive medicine. With software deployed in over 70 clinics across 30 countries, IVF 2.0 continues to lead in leveraging AI to optimize IVF treatment.
4 | Siemens Healthineers Receives FDA 510(k) Clearance for MAMMOMAT B.brilliant Mammography System
Siemens Healthineers has received FDA 510(k) clearance for the MAMMOMAT B.brilliant, marking the introduction of a completely redesigned mammography platform. This clearance encompasses full-field digital mammography, breast biopsy, and titanium contrast-enhanced mammography, with new features aimed at enhancing user ergonomics, workflow, and patient comfort. The system's advancements include a prominent display monitor for clear visibility of patient information, automated ergonomic features to reduce physical strain on technologists, and a laser positioning guide for accurate breast positioning. Additionally, the upcoming 3D portion, named PlatinumTomo, features new acquisition technology with a wider angular range for improved depth resolution and tissue separation, alongside UltraHD reconstruction technology for customizable image impressions and synthetic 2D and 3D imaging.
5 | Midi Health Closes $60M Series B Round Led by Emerson Collective
Midi, a healthcare platform dedicated to midlife women's health, emphasizes understanding and addressing the symptoms of hormonal changes during perimenopause and menopause. Their recent $60 million Series B funding round, led by Emerson Collective and joined by notable investors like GV and Memorial Hermann, marks advancement in efforts to address women’s experiences with midlife healthcare, challenging the current system's tendency to misdiagnosis and undertreatment.
Mika Health, in collaboration with AstraZeneca and Daiichi Sankyo, announced the launch of the UNITE initiative at the HLTH Europe conference, providing personalized digital therapeutic support for breast cancer patients in Switzerland. This initiative aims to enhance treatment experiences through the Mika Health app, which offers mental health coaching, AI-enabled personalized recommendations, and daily symptom monitoring. Mika Health's platform, a certified Class IIa medical device, has demonstrated improvements in managing depressive moods and chronic fatigue among cancer patients. The partnership underscores the increasing importance of digital therapies in modern oncology, aiming to improve patient outcomes and quality of life.
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