Direct-to-consumer (DTC) testing can take the form of at-home testing, at-home sample collection, or traditional phlebotomy/laboratory testing at a clinical laboratory. Post-COVID pandemic, we have experienced both a rise and a fall of DTC testing. Some companies have filed for bankruptcy, while others are thriving. This presentation will discuss long-term strategy that focuses on enhancing clinical utility and adoption.

Point-of-care technologies have been critical in streamlining medical care and public health efforts. A burgeoning infrastructure is rapidly advancing the state of point-of-care devices. From synthetic biology, to robotics, to digital health, a new ecosystem is developing and with it advances that can alter the position of POC testing in our daily lives, in the clinic, and in the home. How to leverage these technologies appropriately and develop them towards mainstream use in healthcare will be the challenge. A discussion of the state of POC.

The rapidly developing technologies of point-of-care diagnostics have great potential to unleash our capacity to deliver more and more care in the healing environment of patients' homes. This session will briefly review the current/emerging acute and advanced at-home care models and then explore point-of-care diagnostic opportunities that enable the monitoring and management of dynamic clinical risk and enable us to safely and effectively serve more patients at home.

Remote specimen collection with samples sent to a central laboratory as well as at-home testing options have shifted the paradigm in the patient journey. The goal of this talk is explore what is needed to support the changing paradigm and reduce barriers for diagnostic testing.

The COVID-19 pandemic accelerated the expansion and acceptance of mobile and at-home testing. With advancements in molecular diagnostics, home-based testing has become more feasible, while the integration of smart devices and artificial intelligence is set to further transform the landscape. This presentation offers an overview of the mobile and at-home testing solutions that emerged during the pandemic and explores future directions, potential opportunities, and challenges in this evolving field.

Direct-access testing (DAT), also known as patient-authorized or direct-to-consumer testing, allows individuals to order laboratory tests without a physician's order. This approach empowers patients autonomy, expands healthcare access, and improves health outcomes. This abstract explores the utility of DAT by examining its benefits and drawbacks, considering its impact on patient care, and discussing its role in the evolving healthcare landscape. When implemented responsibly and ethically, can serve as a valuable tool for enhancing accessibility and promoting individual health management. However, there is still an unmet need for ongoing research and collaboration in the field to optimize the benefits of DAT.

As AI and machine learning (ML) become integral to medical digital solutions, ensuring quality while collaborating with external suppliers presents new complexities. Regulatory compliance, data integrity, algorithm transparency, and model lifecycle management must be rigorously controlled to maintain patient safety and product effectiveness. This talk will explore the key challenges in supplier collaboration, including managing third-party AI/ML components, data sourcing risks, software lifecycle oversight, and cloud-based deployments. We will discuss best practices for supplier qualification, continuous monitoring, and contractual frameworks that align with evolving regulatory expectations for AI-driven healthcare solutions. Real-world case studies will illustrate how proactive collaboration, risk-based assessments, and interoperability strategies can enhance the reliability and regulatory compliance of AI/ML-powered digital diagnostics. Attendees will gain actionable insights into mitigating supplier-related risks while fostering innovation in AI-driven medical digital solutions.

Precision Medicine has rapidly evolved over the last decade; as a part of the dynamic future of healthcare, where do we stand with payer coverage and reimbursement?   What steps can we take to better understand how coverage decisions are going to be made and what steps can be taken "pre" and "post" market entrance to help support coverage?