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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

How AI-Based Drug Repurposing Could Help Prevent Repetitive Behavior Disorders

by Jinhan Kim, Co-founder and CEO, Standigm 11/30/2022 Leave a Comment

How AI-Based Drug Repurposing Could help Prevent Repetitive Behavior Disorders

Repetitive behavioral disorders such as obsessive-compulsive disorder (OCD), Tic Disorder and Tourette Syndrome have been challenging to treat because they involve considerable complexity. For example, the symptoms of one disorder can vary among individuals as does the coexistence or non-existence of other behavior disorders such as anxiety and depression. Further, the treatment of OCD, Tic Disorder and Tourette Syndrome varies depending on
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How Will New FDA Hearing Aid Regulations Impact Health Plans?

by Thomas Tedeschi - Chief of Audiology, Amplifon Americas 11/25/2022 Leave a Comment

How Will New FDA Hearing Aid Regulations Impact Health Plans?

The time has finally arrived. The Food & Drug Administration’s new over-the-counter (OTC) hearing aid regulations are now in effect and health plans are starting to explore what it means for them. Among the many questions they may need to grapple with, a few are particularly salient: - How will the new rules impact their benefit offerings?  - What new opportunities will arise?  - What potential pitfalls should they be aware of?    Introducing OTC hearing
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Cognoa Appoints Former CMO, Dr. Sharief Taraman as CEO

by Jasmine Pennic 11/17/2022 Leave a Comment

Cognoa Appoints Former CMO, Dr. Sharief Taraman as CEO

What You Should Know: - Cognoa, a pediatric behavioral health company appoints Dr. Sharief Taraman as Chief Executive Officer. Dr. Taraman previously served as Cognoa’s Chief Medical Officer and brings nearly two decades of clinical specialization in neurodevelopmental conditions, clinical informatics, and business acumen. - Dr. Taraman served as the company’s Chief Medical Officer since 2017, leading clinical evidence generation and regulatory milestones of Canvas Dx and those resulting
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HLTH22 Day 2 News Summary: Amazon Clinic Launch, General Catalyst, Verizon, Higi

by Fred Pennic 11/15/2022 Leave a Comment

17 HLTH 2022 Predictions from Digital Health Executives to Watch

Amazon Launches Amazon Clinic Across 32 States Amazon launches Amazon Clinic, a virtual care option that will operate across 32 states that offers up-front pricing, and treatment within hours, instead of days—helping customers achieve better health. Welcome to easy-to-use, effective care for common health conditions. For customers, the cost of consultations will vary by provider and includes ongoing follow-up messages with their clinician for up to two weeks after the initial
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ConcertAI CEO Talks COVID-19  & The De-Risking of Technology to Keep Trials Moving

by Fred Pennic 11/09/2022 Leave a Comment

ConcertAI CEO Talks COVID-19 & The De-Risking of Technology to Keep Trials Moving

Nothing like it had ever happened before – a global slowdown in new study starts and a massive decrease in trial accruals for open studies. The turn of events was a shock for sponsors and providers. Sudden disruptions on that scale rarely hit multiple players in an ecosystem at the same time. But that’s exactly what happened at the intersection of clinical care and clinical development during the pandemic. Researchers and clinicians were forced to change how they operated trials, and
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TytoCare Launches the Home Smart Clinic, the First Remote Primary Care Offering for the Entire Family

by Syed Hamza Sohail 11/09/2022 Leave a Comment

TytoCare Launches the Home Smart Clinic, the First Remote Primary Care Offering for the Entire Family

What You Should Know: - TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced the launch of the Home Smart Clinic, a multi-pronged offering delivering health plans and providers a comprehensive range of elements required to launch a truly successful virtual care program without compromises. - The Home Smart Clinic is proven to reduce the total cost of care (TCC) for health plans by 10% on average, to deliver 59% more accurate diagnoses
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Numares Health & Mayo Clinic Expands AI-Enabled Diagnostic Testing Collaboration

by Fred Pennic 11/03/2022 Leave a Comment

Numares Health & Mayo Clinic Expands AI-Enabled Diagnostic Testing Collaboration

What You Should Know: - Mayo Clinic and Numares Health have expanded their collaboration recently to develop AI-enabled diagnostic testing that is more accurate and reliable than current U.S. tests for patients with chronic diseases, including kidney, cardiovascular, liver and neurologic conditions. - The expanded collaboration builds on Mayo Clinic's clinical research support for Numares Health to include an innovative convertible equity investment. AI-Enabled
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3 Reasons to Implement an IDMP Solution Early

by Robin Schilling, Global Project Manager IDMP at ArisGlobal 11/02/2022 Leave a Comment

The European Union (EU) has announced guidance on the Identification of Medicinal Product (IDMP) — and pharmaceutical companies around the world should take notice. While the EU will be the first to design and implement IDMP, other countries, including the United States, will need to begin following suit. It’s imperative that companies begin evaluating what changes need to be implemented, and the sooner pharmaceutical companies act, the better.  Designed to connect data elements and
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Patching Cybersecurity Gaps in Healthcare, with New FDA Guidelines and Zero Trust

by Trevor Dearing, Director of Critical Infrastructure Solutions at Illumio 10/27/2022 Leave a Comment

Patching’ Cybersecurity Gaps in Healthcare, with New FDA Guidelines and Zero Trust

When it comes to protecting patients from the impacts of ransomware, the time has come for the healthcare sector to rethink the way it approaches cyber resilience -- starting with Zero Trust strategies.  The unprecedented wave of ransomware attacks on the healthcare sector has upended long-held assumptions about network security. Confidence in traditional methods alone and the philosophies behind them, have been undermined. The ransomware era has become a time of reckoning – particularly
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COTA Secures New Financing to Accelerate Cancer Research and Treatment Innovation

by Jasmine Pennic 10/25/2022 Leave a Comment

FDA Extends RCA With COTA to Explore COVID's Effect on Cancer

What You Should Know: - COTA, Inc., an oncology real-world data and analytics company, announced its latest financing by an investment fund managed by Deerfield Management and additional capital from existing investors. - The company will use this new funding to further expand its real-world data platform and services in order to drive more efficient and inclusive drug development in oncology. - Perella Weinberg Partners LP served as exclusive financial advisor and Goodwin Procter
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