Innovations in Health Care Delivery

In this episode of the Diagnosing Health Care Podcast A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

Continue Reading Podcast: Direct Access Laboratory Testing – Physician Orders and Specimen Collection – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it.

What unique challenges do direct access tests (DATs) pose when it comes to reimbursement and related compliance requirements?

Continue Reading Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  What are the various factors impacting stakeholders in the direct access testing industry?

By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.

Continue Reading Podcast: Direct Access Laboratory Testing: Navigating the Regulatory Landscape – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:   The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.

How has this document caused confusion for industry? How can companies respond?

Continue Reading Podcast: Unpacking FDA’s Final Clinical Decision Support Guidance – Diagnosing Health Care

Featured on the Diagnosing Health Care Podcast:  How is openEHR transforming the way health data is managed and stored across Europe? Will it soon disrupt the U.S. marketplace?

In this episode of our special series on interoperability, hear from Alastair Allen, CTO of Better.

Continue Reading Podcast: Interoperability: Health Care’s Next Disruptor Is openEHR – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  In the past decade, certified electronic health records (EHRs) have been instrumental in transforming medical records from paper to digital formats.

What obstacles are currently preventing providers from sharing patient data with each other or patients from sharing health information from their personal devices with their providers? In this episode of our special series on interoperability, hear from Tomaž Gornik, founder and CEO of Better.

Continue Reading Podcast: Interoperability: A New Vision Through openEHR – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.

Continue Reading Podcast: Entrepreneurship in Biotech: Growing Your Business – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  The interoperability and information-blocking rules have imposed new regulations and requirements on health information exchanges (HIEs). How are HIEs responding to these new regulations in a space they have been in for decades? In this episode of our special series on interoperability, hear from Dan Paoletti, CEO of the Ohio Health Information Partnership.

Continue Reading Podcast: Interoperability: The Role of Health Information Exchanges – Diagnosing Health Care

New from the Diagnosing Health Care Podcast:  One of the long-term goals of the interoperability and information-blocking rules is to give health care providers a much more comprehensive view of a patient’s entire continuum of care.

Continue Reading Podcast: Interoperability: The Provider Perspective – Diagnosing Health Care

The application of artificial intelligence technologies to health care delivery, coding and population management may profoundly alter the manner in which clinicians and others interact with patients, and seek reimbursement. While on one hand, AI may promote better treatment decisions and streamline onerous coding and claims submission, there are risks associated with unintended bias that