Mobi Health News

DECEMBER 21, 2018

The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.

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Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. Epub ahead of print. PMID: 35201276.

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The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

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Bill of Health

JUNE 20, 2023

Melflufen: post-hoc subgroup analyses and the US FDA Oncologic Drugs Advisory Committee. Physician Perspectives on FDA’s Decision to Grant Accelerated Approval to Aducanumab for Alzheimer’s Disease. Cliff ERS, Janakiram M, Kesselheim AS. Lancet Haematol. 2023 May;10(5):e314-e317. Michaeli T, Jürges H, Michaeli DT.

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HIPAA Journal

NOVEMBER 16, 2022

healthcare organizations, the Food and Drug Administration (FDA) asked MITRE to develop a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook to help hospitals and healthcare delivery organizations (HDOs) develop a cybersecurity preparedness and response framework.

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. For example, in furtherance of the laudable goal of enhancing access and affordability of hearing healthcare, the FDA does not require that a hearing health professional verify a member’s hearing loss to be eligible for an OTC device. Introducing OTC hearing aids.

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Health Populi

MAY 29, 2018

Trust has become a key currency in provider/patient/supplier relationships: 94% of health executives say treating customers as partners is important to gain trust, according to the Digital Health Tech Vision 2018 from Accenture. Finally, the Internet of Thinking rounds out Accenture’s five themes in the 2018 Health Tech Vision.

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Sharps Compliance

MAY 11, 2022

Between 2010 and 2018, there were 48,000 accidental prescription opioid exposures among young children.3. Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog.

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Mobi Health News

APRIL 30, 2018

At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.

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Mobi Health News

AUGUST 23, 2022

Formerly known as IDx, the company received FDA De Novo clearance in 2018 for its IDx-DR system used to detect diabetic retinopathy.

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Bill of Health

MAY 19, 2022

from 2018-2019. Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019. A full posting of abstracts/summaries of these articles may be found on our? Aboy M, Liddell K, Jordan M, Crespo C, Liddicoat J. European patent protection for medical uses of known products and drug repurposing. JAMA Oncol.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Healthcare It News

MARCH 18, 2022

Notably, since 2018, mental health has been the top clinical indication to receive investment, growing from $1.4 Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. billion that year to $5.1

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HIT Consultant

MAY 22, 2024

Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE). – The five-year extension builds upon a successful partnership established in 2018 and signifies a continued commitment to utilizing real-world data (RWD) to enhance cancer treatment and regulatory decisions. Wang, COTA’s chief medical officer.

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Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ).

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C&M Health Law

NOVEMBER 3, 2022

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). If this latest draft guidance is finalized after a period of public comment, the agency will incorporate the proposed language into the 2018 guidance.

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Bill of Health

MARCH 24, 2023

US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. JAMA Intern Med. 2023 Feb 13:e226444. Epub ahead of print. Naci H, Forrest R, Zhai M, Stofesky AR, Kesselheim AS.

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Health Law Advisor

MAY 19, 2022

The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% 9-THC concentration of not more than 0.3 Fighting Cancer. ?

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Electronic Health Reporter

MAY 1, 2019

In December 2018, the FDA announced its new framework for the real world evidence (RWE) program, which would require including imaging data alongside claims, electronic health records (EHRs) and other datasets in clinical research. This article is copyrighted strictly for Electronic Health Reporter. Illegal copying is prohibited.

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FDA 89

Bill of Health

SEPTEMBER 13, 2023

His current research focuses on tensions between the patent incentive system, the FDA approval process, and insurance carriers. In the past, Adithi also published work on representation of the Global South and equitable authorship in global health scholarship (The Lancet Global Health, Jan. Vincent Joralemon is a law student (J.D.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

According to a 2018 report from Deloitte , the IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022. Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification.

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FDA 52

Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. According to a 2018 Deloitte Consulting report, the market for interconnected medical devices is expected to grow from $15 billion in 2017 to $52 billion by 2025. Medical device industry is changing fast!

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FDA Medical Device Industry Doctors Regulatory Compliance 52

Health Populi

NOVEMBER 8, 2018

Adults Aged 18 and Over , published in November 2018. Headspace is a well-adopted app for meditation, getting traction in healthcare with research partners at Carnegie Mellon, Harvard, and Kaiser Permanente who are studying the app to collect data for FDA scrutiny. One in five women do yoga in America.

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Health Populi

JUNE 5, 2022

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. “Among the 184 most commonly prescribed drugs in Medicare Part D in 2018, 90% could be purchased at Costco for less than $20 for a 30-day supply.”

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Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

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HIT Consultant

DECEMBER 5, 2024

The AI might misinterpret images from patients with darker skin tones and fail to diagnose melanoma due to sampling bias (Adamson & Smith, 2018). Food and Drug Administration (FDA) regulates AI-based medical devices under its software as a medical device (SaMD) category. Regulatory Guidance Oversight by the U.S.

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Healthcare IT Today

MARCH 29, 2024

Founded in 2018, Overjet has already raised the standard for diagnosing diseases in X-rays, educating patients about their oral health, and reviewing dental insurance claims. Food and Drug Administration (FDA) to detect, outline, and quantify instances of oral disease, with millimeter-level precision.

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HIT Consultant

JANUARY 21, 2022

– The Series B funding will allow Casana to accelerate FDA submission of the Heart Seat with the goal to obtain FDA approval and bring this important new device to patients in 2022. The Heart Seat has already been tested through multiple peer-reviewed research studies and is currently pursuing FDA clearance.

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Health Populi

AUGUST 9, 2019

Gallup calls out the 2018 Farm Act which legalized the cultivation of hemp, which is one driving force behind the fast-growing supply side of CBD-based products. Now that I’ve explained the bullish forecast and consumer race to adopt CBD, let’s hear from the FDA which, so far, hasn’t yet issued regulations about CBD.

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FDA 101

Health Law Advisor

MARCH 3, 2023

Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk. On February 22, 2023, the U.S.

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Mobi Health News

MARCH 1, 2018

Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.

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Healthcare IT News - Telehealth

FEBRUARY 6, 2024

"RPM has become more widely used and accepted since the creation of independent billable CPT codes in late 2018, which can be billed independent of home health episodes – normally a bundled payment for all services rendered."

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Health Blawg

MAY 28, 2018

Eugene and his team are just getting this off the ground (Summer 2018). Eugene and his team are just getting this off the ground (Summer 2018). Everyone loves change, but nobody wants to change.”. Join the conversation on Twitter at #HarlowOnHC. David Harlow. The Harlow Group LLC. Health Care Law and Consulting.

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HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. FDA website, December 8, 2017.

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