HIT Consultant

AUGUST 23, 2023

What You Should Know: Welldoc® , a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.

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Dot Compliance

FEBRUARY 15, 2024

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule. director of the FDA’s Center for Devices and Radiological Health. What Is QMSR?

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McGuire Wood

OCTOBER 12, 2023

Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety requirements for medical devices. To strengthen the QSR metrics, the FDA recommends implementing a secure product development framework (SPDF) to address cybersecurity risks. 27, 2023, the U.S.

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Bill of Health

APRIL 7, 2024

In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Exciting as this is, cell therapies face complex regulatory schemes and various levers to the process of FDA approval. Are they classifiable as regenerative therapies for life-threatening conditions ?

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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 ). In its February 2022 report, the U.S.

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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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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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Bill of Health

MARCH 27, 2024

By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. This is typical—without a seal of approval from FDA, insurers are reluctant to pay for off-label treatments. for depression).

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Healthcare IT News - Telehealth

MAY 18, 2021

Amazon is reportedly weighing the launch of a service offering at-home medical tests, signaling yet another foray into healthcare from the technology giant. And, of course, there's Amazon Care – the company's telehealth project that will soon deliver app-based services to all 50 states. ON THE RECORD.

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HIT Consultant

AUGUST 2, 2023

Sonio has received Regulatory Class II FDA clearance for Sonio Detect , a product that uses AI to ensure high-quality exams, automatically detecting views and quality criteria of ultrasound images. Sonio has made a commitment to bring the best of technology and clinical expertise at the service of medical performance and access.

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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 23, 2020

Nurx and Carbon Health have officially halted their mail-order testing kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.

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HIT Consultant

JULY 22, 2022

What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. The Zio Watch is designed to be a cost-effective, non-invasive monitoring solution and will fully integrate with the Zio service.

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HIT Consultant

NOVEMBER 16, 2021

Food and Drug Administration (FDA) has granted de novo approval for its flagship immersive therapeutic, EaseVRx, to treat chronic low back pain, which previously received breakthrough device designation in 2020. The news also comes on the heels of AppliedVR announcing its $36M series B funding round, bringing its total funding to $71M.

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Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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Bill of Health

OCTOBER 17, 2023

Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues , rather than saliva , now brings us to a new, increasingly complex inflection point. And what would that mean for patients? Our Cells in Whose Hands?

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. – Aftercare service : Whether to offer virtual support and/or an optional care package purchased by members at a clinic? – What new opportunities will arise? – What potential pitfalls should they be aware of? Introducing OTC hearing aids.

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. Chances of Success by Topic Given those topics, I wanted to understand which topics are likely to succeed in getting information from FDA. FOI Services, on the other hand, likes to ask for a lot of 510(k)’s.

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Bill of Health

NOVEMBER 30, 2022

Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public.

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HIT Consultant

MARCH 7, 2022

What You Should Know: – GoodRx announced that it will acquire vitaCare Prescription Services, a tech-enabled pharmacy services platform that expands GoodRx’s offering to pharma manufacturers while improving patient access and adherence to affordable brand drugs. CEO at vitaCare Prescription Services.

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HIT Consultant

FEBRUARY 14, 2024

– Paving the way for DTx: Curavit’s HEOR services help DTx companies gather real-world data to secure market access and impact patient lives. . – Market access and affordability: Demonstrating healthcare economic value can lead to wider insurance coverage and reimbursement.

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Fierce Healthcare

JUNE 1, 2023

The Centers for Medicare and Medicaid Services outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration | CMS outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration. (..)

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HIT Consultant

NOVEMBER 30, 2021

What You Should Know: Labcorp announced that it is offering an observed collection of COVID-19 PCR testing in over 500 patient service centers nationwide. Food and Drug Administration (FDA), and worked with companies to develop COVID-19 vaccines and therapies. Labcorp became the first U.S.

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Bill of Health

DECEMBER 26, 2023

By Hannah Rahim The Americans with Disabilities Act (ADA) prohibits health care organizations that provide services to the public from discriminating against persons with disabilities. Further action is needed to prevent discrimination in health care services towards persons with substance use disorder.

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Health Populi

MARCH 25, 2024

Together, these products reflect a shift in health care empowerment toward patients as consumers with greater autonomy over their health care when the products and services are accessible, affordable, and designed with the end-user central to the value proposition and care flows.

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HIT Consultant

APRIL 12, 2024

What You Should Know: – Philips Respironics , a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania.

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Bill of Health

OCTOBER 27, 2023

By Adithi Iyer In my last piece , I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. After all, data collection and use is the bread and butter of these services.

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Health Law Advisor

SEPTEMBER 12, 2023

On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In addition, only certain components of FDA’s eight-factor analysis bind the DEA. heroin, LSD, and ecstasy).

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HIT Consultant

NOVEMBER 30, 2023

Annalise Triage boasts an impressive array of 12 FDA-cleared findings, covering 5 for chest X-ray (CXR) and 7 for non-contrast brain CT (CTB). This comprehensive offering has received 510(k) clearances and the coveted FDA breakthrough designation for obstructive hydrocephalus.

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Compliance Now

JANUARY 20, 2022

The ACA requires non-grandfathered health plans to pay for “preventive care” on a first-dollar basis, meaning that no copays, coinsurance, or deductibles can be charged for certain services defined as “preventive” under these rules. Thus, these colonoscopies and the associated services must also be provided at no cost to the participant.

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Digital Health News

SEPTEMBER 8, 2023

The latest Digital Health News industry roundup features Thai FDA approval for DeepTek's AI tech and a rebranding and new logo for SPARK TSL.

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Compliance Now

MARCH 8, 2022

The HRSA, which maintains responsibility for the comprehensive guidelines for women, recently issued new guidance that updates and expands the list of women’s preventive services. An update to the list of women’s contraceptives found in the FDA Birth Control Guide. no co-payments, co-insurance, or deductibles may be applied).

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HIT Consultant

FEBRUARY 6, 2024

Zerneke joins Zerigo Health from Amazon Health Services, where he led business development and strategy. Their FDA-cleared handheld NB-UVB light device, paired with a user-friendly smartphone app and expert health coaching, provides a convenient and cost-effective alternative to traditional in-office treatments.

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Healthcare Law Today

NOVEMBER 9, 2022

Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” CMS also extended coverage for SUD treatment services provided via telehealth.

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HIT Consultant

JULY 14, 2022

Wysa uses AI (Artificial Intelligence) to triage users according to their personal needs, guiding them through appropriate, evidence-based CBT (Cognitive Behavioral Therapy) exercises within the app, towards other mental health services or crisis support. FDA Breakthrough Device Designation. million people across 65 countries.

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HIT Consultant

OCTOBER 25, 2022

– 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. COTA Expands Services and Approaches Milestone of 2 Million Cancer Lives. What You Should Know: – COTA, Inc.,

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Fierce Healthcare

NOVEMBER 30, 2023

TytoCare's primary care offering includes an FDA-cleared hand-held solution for remote physical exams and diagnoses as well as AI-enabled diagnostic support and a suite of user engagement services. Luke’s Health Plan access to its Home Smart Clinic.

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Healthcare It News

APRIL 27, 2023

With data from more 11,000 individuals monitored during the COVID pandemic, DoD can issue commercial wearables "to noninvasively monitor a service member’s health and provide early alerts to potential infection before it spreads," said Jeff Schneider, program manager for the RATE, in a statement.

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