HIT Consultant

FEBRUARY 8, 2024

AI-Powered Clinical Trials with Digital Twins Founded in 2017, Unlearn has consistently pushed the boundaries of AI in clinical research. Their innovative technology holds immense potential to accelerate medical advancements and improve patient outcomes worldwide. founder and CEO of Unlearn.

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Regulatory Compliance FDA Health Outcomes Compliance 97

Bill of Health

MARCH 24, 2023

Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D. JAMA Health Forum. 2023 Feb 3;4(2):e225610. Pham C, Le K, Draves M, Seoane-Vazquez E. JAMA Intern Med. 2023 Feb 13:e226787. Epub ahead of print.

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HIT Consultant

FEBRUARY 27, 2023

Digital Automation with Radar Accuracy Founded in 2017 as a US Delaware C-Corp with international operations spanning South Korea, Canada and the United States, Xandar Kardian is led by CEO and founder Sam Yang with a mission of deploying reliable and high-accuracy cleantech, smart building and healthcare solutions worldwide.

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Healthcare It News

NOVEMBER 16, 2023

Forward Health launches staffless CarePods Forward Health, which launched its AI-driven medical concierge service in 2017, announced it will soon bring doctor-built CarePods – stand-alone medical diagnostic rooms – to major cities like San Francisco, New York and Chicago. breast screening market.

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Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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HIT Consultant

OCTOBER 9, 2022

– The multi-center study evaluated the FDA-cleared EyeArt AI system against dilated eye exams performed by general ophthalmologists and retina specialists on the same cohort of 521 study participants. The study design was a prospective, pivotal, multi-center trial conducted from April 2017 to May 2018. Participants were ?18

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Healthcare IT Today

FEBRUARY 29, 2024

Founded in 2017 as an AI research company, Unlearn has always been at the forefront of developing innovative AI-based solutions for clinical trials. Their methods using participants’ digital twins are qualified by the European Medicines Agency and align with current FDA guidance. For more information, please visit unlearn.ai

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Mobi Health News

JANUARY 10, 2019

In December 2017, the company’s assay FoundationOne CDx received approval from the US Food and Drug Administration (FDA). The company develops, manufactures, and sells genomic profiling assays based on next-generation sequencing technology for solid tumours, hematologic malignancies, and sarcomas.

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HIT Consultant

MARCH 9, 2022

Founded in 2017, MediView uses augmented reality to provide surgeons with intraoperative 3D “x-ray” holographic visualization. – The XR90 Augmented Reality Surgical Navigation System , MediView’s flagship product, is slated for FDA submission in the second half of 2022. Healthcare Metaverse Has Arrived.

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Healthcare IT News - Telehealth

MAY 9, 2022

Between 2017 and 2020, 113 women died from pregnancy-related causes, while 177 deaths during that period were deemed to be "pregnancy-associated." In December 2021, the FDA opted to permanently modify its regulations, thereby enabling abortion via telehealth in more than half the country. " Black women were 2.5

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Health Populi

AUGUST 12, 2021

In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls. . “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis. million units with revenues of $4.5 billion.

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HIT Consultant

OCTOBER 16, 2023

How Ozempic Works: The Basics Ozempic is a weekly injection containing the active ingredient semaglutide, FDA-approved in 2017 for adults with Type 2 diabetes. While Ozempic is not yet FDA-approved specifically for weight loss, some medical professionals are considering its “off-label” use as a weight-loss solution.

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Mobi Health News

MAY 25, 2018

Dexcom started out the year strong following the FDA clearance of its integrated continuous glucose monitor the G6. In its Q1 earnings call, the company reported a 30 percent increase in revenue compared to Q1 of 2017, bringing its total revenue to $184 million.

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HIT Consultant

JUNE 28, 2023

Founded in 2017, Gleamer’s suite of AI-powered solutions supports radiologists and clinicians in their diagnoses, thereby improving reliability and reducing the time taken to read and process examinations.

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Healthcare It News

OCTOBER 13, 2021

"In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said. "That same year, FDA approved smart pills. "In the five years since I last talked at CHC, there have been some amazing medical breakthroughs," said Feinberg in his virtual keynote address.

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HIT Consultant

OCTOBER 14, 2022

Obatala Sciences, a New Orleans biotechnology company, was founded in 2017 to enable diversity in clinical research and speed up the development of better therapies for diseases like obesity, diabetes, and cancer, and advance research in tissue engineering and regenerative medicine.

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Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

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Health Populi

OCTOBER 8, 2021

Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA. The phrase “concerned embrace” was coined in a 2017 Deloitte consumer study on mobile technology trends. FDA clearance makes a difference in peoples’ trust with health apps, with 2 in 3 U.S.

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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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Health Populi

NOVEMBER 8, 2018

substantially grew between 2012 and 2017, many more women than men use these holistic medicine approaches. In 2017, 14.3% 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.

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NY Health Law

JULY 9, 2019

More than 70% of CBD extracts sold online, for instance, were mislabeled regarding potency, according to a Penn Medicine study in 2017. The FDA is struggling to determine how to regulate CBD. The FDA is also gathering data from the public through the use of a docket that is open for comment until July 16, 2019.

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Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

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US Department of Health and Human Services FDA Public Health COVID-19 52

Dot Compliance

FEBRUARY 8, 2022

Regulatory bodies, namely the FDA and IMDRF, have issued regulations that apply to given software applications used on mobile applications and general-purpose platforms alike. However, ongoing innovations create new challenges on a regular basis for developers.

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Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. The team analyzed data-sharing guidelines across 230 policy documents published between 1996 and 2017. into the precision medicine category. Note that autonomy and privacy rank with the most mentions.

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Health Populi

OCTOBER 6, 2021

That post was written in tandem of CES 2017 when I did a deep dive into the potential for autos to bolster wellness and promote safety and hygiene (well pre-COVID).

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Health Populi

JANUARY 31, 2018

In 2017, Hugh Langley wrote in Wareable that, “blood pressure is wearable tech’s next challenge.” Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist.

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Pharmacy Law Blog

MARCH 13, 2018

On December 4, 2017, a Florida federal judge refused to dismiss the federal government’s False Claims Act (FCA) suit against a compounding pharmacy. December 4, 2017). December 4, 2017). By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law. To read the court’s order in full, click here. Raymond, Nate.

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Dot Compliance

JANUARY 14, 2022

EU MDR 2017/745. The European Union Medical Device Regulation (Regulation (EU) 2017/745, MDR) establishes the restrictions and requirements on the manufacturing and design of medical devices. FDA’s Safer Technologies Program (SteP) for Medical Devices. Source: [link]. Source: [link].

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Health Populi

DECEMBER 27, 2021

That post was written in tandem of CES 2017 when I did a deep dive into the potential for autos to bolster wellness and promote safety and hygiene (well pre-COVID).

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HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

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Health Populi

FEBRUARY 19, 2019

Some innovators have invested the time and money to undergo FDA clearance; some have collaborated with health care providers and researchers to build evidence cases and calculate cost-effectiveness or ROI for their use. Telehealth adoption also grew from 2017 to 2018. Live video use roughly doubled, from 19% in 2017 to 34% in 2018.

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Health Populi

DECEMBER 20, 2018

Back in 2017, I spoke with Ranndy about the vision for BP measurement for Everyday People that would be a streamlined, simple consumer experience that the traditional armband and pump didn’t offer. It may sound high, but an Apple Watch hasn’t yet been cleared by the FDA to take clinically validate blood pressure.

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HIPAA Journal

DECEMBER 8, 2022

The FDA should also make it clear that security updates are required, not optional. CHIME/AEHIS recommend the FDA and OCR better align their guidance and enforcement activities, specifically to ensure that medical device manufacturers are meeting their obligations as HIPAA business associates. Patient privacy.

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Health Populi

APRIL 23, 2018

in 2017 after accounting for discounts and rebates. The report reviews medicines spending in 2017 looking forward to 2022. billion prescriptions dispensed in 2017, and generic drugs accounted 90% of them. That’s the navy blue component in each bar, indicating the $5 bn drop in 2017). In 2017, patients spent $57.8

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Health Populi

JANUARY 9, 2019

By 2017, these costs were $11 on average for a generic, $33 for a brand on the approved list, and $59 for a third-tier brand off the formulary. Thus, the difference between a Tier 1 generic and Tier 3 off-formulary drug was nearly $50 in 2017. The patient is a consumer is a payor, right? $50

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SQA

JUNE 10, 2021

183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices. The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017.

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HIT Consultant

MAY 9, 2022

While 86 percent of patients still receive paper medical bills, 68 percent of healthcare consumers prefer electronic payment options, according to survey results released by Instamed in 2017. If this documentation is primarily paper-based, researchers could have a difficult time ensuring each piece of documentation meets FDA standards.

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