HIPAA Journal

NOVEMBER 16, 2022

In the event of a cyberattack that impacts the functionality of medical devices, a rapid and effective response is essential to ensure patient safety and the continuity of clinical operations. The post FDA, MITRE Update Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook appeared first on HIPAA Journal.

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HIT Consultant

MAY 17, 2024

What You Should Know: – Implicity , a leader in remote patient monitoring and cardiac data management, has received FDA 510(k) clearance for SignalHF1 , a groundbreaking new algorithm within their remote monitoring solution. Making a Difference for All Patients SignalHF1 stands out for its versatility.

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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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Hall Render

JUNE 21, 2024

Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). In May 2024, the U.S. Below are some highlights from the Final Guidance.

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HIT Consultant

APRIL 12, 2022

What You Should Know: – Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally. – The algorithm will soon be available to users in the U.S. Why It Matters.

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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. Complaint Investigation/Adverse Events 3. NDA/Adverse Event Report 7. FOI Services submitted a lot of requests, but their success rate was proportionately not as good as FDA News, for example.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. Complaint Investigation/Adverse Events 3. NDA/Adverse Event Report 7.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

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Mobi Health News

AUGUST 23, 2018

Online patient community PatientsLikeMe, which connects patients with different symptoms and conditions and collects patients' voluntarily submitted data for research, has teamed up with the FDA on a research study that could point the way toward a new channel for patient-generated health data for the agency.

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Kaiser Health News

OCTOBER 7, 2024

senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.

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Health Law Advisor

MAY 19, 2022

In September 2021, the Food and Drug Administration (FDA) issued and updated a consumer advisory outlining consumer safety concerns related to delta-8 products. The Centers for Disease Control and Prevention issued similar guidance warning consumers of the rise in hospitalization reports and adverse event incidents related to delta-8 THC.

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Compensation and medical treatment in event of injury. On August 15, 2023, the U.S.

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Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. Limitations on the Capability of the FDA to Advise.

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HIT Consultant

SEPTEMBER 26, 2024

Food and Drug Administration (FDA) has recently emphasized the importance of assessing genomic integrity, including the detection of chromosomal abnormalities such as copy number variations (CNVs), to ensure clinical safety.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview.

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HIT Consultant

MARCH 6, 2024

This influx of capital marks a pivotal moment in BHT’s mission to reshape bone health for postmenopausal women, closing right in time for de novo FDA clearance. Osteoboost stands out as the premier non-pharmacological FDA-cleared prescription device tailored to address this lucrative $30 billion market.

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Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices. One such example is the Control-IQ technology , a software product recently classified by the FDA as a Class II medical device.

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Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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Bill of Health

APRIL 28, 2023

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship !

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HIT Consultant

FEBRUARY 19, 2023

Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), now expect PROs to be included in study protocols, objectives and even labeling claims. The FDA has identified 5 core aspects of the patient experience to consider throughout the development of an eCOA: 1.

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Mobi Health News

MARCH 21, 2022

The device, which is not yet cleared by the FDA, alerts bystanders to a potential cardiac event nearby and guides them to the scene.

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Healthcare IT Today

SEPTEMBER 21, 2024

Read more… FDA FHIR Pilot Automates Adverse Events Reporting and Validation. Jay Nakashima at eHealth Exchange detailed how California’s Cedars-Sinai used FHIR to send adverse events related to COVID-19 vaccines to the FDA – a process that replaced manual data entry and faxing.

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Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

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HIT Consultant

MAY 31, 2022

What You Should Know: – Akili’s EndeavorRx , the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership. . No serious adverse events were associated with its use.

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HIT Consultant

JULY 10, 2024

. – These AI enhancements cater to the evolving needs of life science organizations, allowing them to navigate increasingly complex regulatory landscapes and manage rising adverse event caseloads. Global Harmonization: CIOMS-I report mappings are harmonized with E2B reports, enhancing report accuracy and comprehensiveness.

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Healthcare IT Today

JANUARY 24, 2024

This year that growth was particularly true thanks to the great efforts of Catherine Pugh who put together an entire Digital Health track, a long list of digital health vendors, and a packed house digital health networking event. They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful.

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HIT Consultant

OCTOBER 7, 2024

CYP2C19 (pronounced “sip 2 C 19”) and CYP2D6 (pronounced “sip 2 D 6”) are the two genes with actionable, high-evidence mental health drug-gene interactions supported by drug or dose adjustment guidance from the Clinical Pharmacogenetics Implementation Consortium (CPIC), the NIH-funded guidelines body, or the FDA.

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Healthcare It News

NOVEMBER 16, 2023

" Aoun said when he founded Forward Health that he was focused on AI that can predict adverse health events. " FDA clears Lunit breast cancer screening algorithm Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, announced Tuesday that the U.S.

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HIT Consultant

AUGUST 2, 2023

The pathway will augment Geisinger’s existing remote heart failure management program by incorporating the FDA-cleared Bodyport Cardiac Scale and Fluid Alerts. Together, Geisinger and Bodypart will develop and implement a fluid-guided care pathway for heart failure.

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HIT Consultant

NOVEMBER 4, 2024

Food and Drug Administration (FDA), the trial aims to assess the system’s safety and effectiveness in achieving procedural success with minimal complications. Conducted under an Investigational Device Exemption (IDE) granted by the U.S.

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HIT Consultant

JUNE 4, 2024

Equipped with FDA-cleared AI applications, it aims to significantly reduce the burden on echocardiography labs and improve overall workflow efficiency. RWMAs are independent indicators of adverse cardiovascular events in patients with heart conditions like myocardial infarction and congenital heart disease.

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HIT Consultant

JUNE 10, 2022

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. The FDA hasn’t just stated its willingness to collaborate with the industry.

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Healthcare IT News - Telehealth

MARCH 14, 2022

The bundle includes the VIVE Flow immersive glasses, preloaded with XRHealth FDA-registered medical applications, and includes a screening video call with an XRHealth clinician. An inside look at the innovation, education, technology, networking and key events at the HIMSS22 Global Conference & Exhibition in Orlando.

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Health Law Advisor

JULY 5, 2022

To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device. The root cause that is labeled “PMA” means that the product had no FDA approval.

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