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. In the post last month, I looked at response times in general. 483/EIR Drug 6.

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HIT Consultant

JANUARY 24, 2023

What You Should Know: – MedCrypt , the proactive cybersecurity solution provider for medical devices and manufacturers, will announce the close of a Series B extension round led by Dexcom Ventures , bringing the company’s total to date to $36.4M. Approximately 37.3 billion and is expected to grow 28% by 2030.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA 60

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA 60

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

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FDA HIPAA Compliance 60

HIT Consultant

NOVEMBER 27, 2023

What You Should Know: – Mass General Brigham , a healthcare provider, and Annalise.ai , a global medical imaging AI company, today announced a strategic collaboration to develop and implement AI-enabled diagnostic products.

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Compliance Now

AUGUST 1, 2022

Covered plans are required to automatically cover a least one form of contraception in each of the categories below without applying medical management. Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above.

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FDA Medicare Medicare Governance 100

HIT Consultant

JUNE 11, 2023

David Barzilai, VP of Sales and Marketing at Karamba Security There is a fine line that connects the cars we drive and the medical devices we occasionally use. The reason is that embedded IoT devices – which both categories are part of – carry significant volumes of legacy software and run on limited-power computing hardware.

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FDA Compliance 95

HIT Consultant

SEPTEMBER 26, 2023

What You Should Know: Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™, to put high-performance medical imaging into the hands—and pockets—of every caregiver. We’re just getting started.”

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FDA Nurses Hospitals Compliance 119

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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FDA Nursing Homes Compliance COVID-19 52

Health Populi

AUGUST 12, 2021

As connected devices proliferate within health care enterprises and across the health care ecosystem, cybersecurity risks abound. In health care, outdated operating systems present some of the greatest risks: 15% of medical devices and 32% of medical imaging tools run on outdated operating systems.

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COVID-19 FDA Public Health Hospitals 174

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. The ones that seem to fall into somewhat defined categories include the following: 2. I looked at response times and then started to dive into the topics that requesters were asking about. 483/EIR Drug 6.

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FDA 52

Health Populi

OCTOBER 6, 2021

Digital health as a category has been a growing feature at CES for over a decade, starting with the early wearable tech era of Fitbit, Nike, Omron and UnderArmour, early exhibitors at CES representing the category. It’s timely, then, that CES launched the Global Women’s HealthTecb Awards collaborating with the World Bank.

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COVID-19 FDA Health Outcomes Doctors 141

Health Law Advisor

JULY 5, 2022

Thus, in terms of metrics, medical device companies should not adopt as a goal reducing recalls, as that will lead to behavior that could put users at risk by leaving bad products on the market. In looking at the data set, it appears that FDA tries to arrive at a conclusion regarding root cause for just about every recall.

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FDA 52

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 biggest challenge for most home health monitoring devices is poor patient compliance. Novel Effortless Home Health Monitoring.

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FDA COVID-19 Doctors Compliance 96

Health Law Advisor

AUGUST 2, 2022

You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful. However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process. The process is likely not helpful for such devices.

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FDA 52

Healthcare IT Today

FEBRUARY 27, 2024

Hamilton Beach Brands Holding Company today announced that, through its Hamilton Beach Health subsidiary, it has acquired HealthBeacon PLC , a medical technology firm and strategic partner of the company. “Hamilton Beach Health continues to explore collaboration opportunities with other companies in the home medical market.”

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FDA Licensing Medicaid Medicaid 83

Health Populi

DECEMBER 27, 2021

Digital health as a category has been a growing feature at CES for over a decade, starting with the early wearable tech era of Fitbit, Nike, OMRON and UnderArmour, early exhibitors at CES representing the category. It’s timely, then, that CES launched the Global Women’s HealthTecb Awards collaborating with the World Bank.

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COVID-19 FDA Health Outcomes Doctors 161

HIT Consultant

OCTOBER 17, 2021

The pandemic has set ablaze the white-hot market for Digital Therapeutics (DTx), which “deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders 1.”

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FDA Health Outcomes Doctors Hospitals 98

Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

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FDA Compliance 52

Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

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FDA Compliance 52

Health Populi

JANUARY 6, 2023

“Despite breathtaking medical advancements since President Harry Truman declared war on heart disease 75 years ago, researchers have observed a disturbing trend that started in 2009: America’s death rate from heart-related conditions is climbing again,” the detailed essay explains. In the U.S.

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FDA Doctors COVID-19 Hospitals 104

Jane Sarashon

JULY 15, 2022

Watch for the emerging segment of over-the-counter hearing aids to ratchet up in growth, with the FDA’s final ruling expected soon. Driving health tech growth in the forecast are connected health monitoring devices: think blood pressure and blood glucose meters which tie to mobile apps via smartphones. About 1 in 5 U.S.

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COVID-19 FDA 98

Dot Compliance

FEBRUARY 8, 2022

The digital revolution and IoMT (Internet of Medical Things) has transformed the healthcare landscape. Software and connected devices are now being used to power disruptive medical technologies and solutions. What is Software as a Medical Device (SaMD)?

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FDA Compliance 52

Health Law Advisor

SEPTEMBER 6, 2022

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. The FDA’s recent activities in the region were well within their historical norms. To be sure, FDA can have multiple reasons for refusing entry.

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FDA Governance Hospitals 52

Dot Compliance

MARCH 30, 2022

Companies that manufacture pharmaceutical, medical, and biotechnology products are required to achieve compliance with an array of safety regulations and quality standards. The bar chart of your defect categories is arranged in descending order, and the line graph is added to track the cumulative percentage total. Source: [link].

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FDA Compliance 52

AIHC

JUNE 14, 2023

AI is advancing rapidly, so we encourage you to reference the new Artificial Intelligence article category for the latest articles. The FTC’s action should help protect healthcare organizations by limiting deceptive or exaggerated promises of what a medical device or AI software can actually do.

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FDA HIPAA Compliance Regulatory Compliance 45

Health Populi

JANUARY 4, 2022

Among the top 10 AI-informed tasks to which people would be open are shopping and purchase recommendations, fitness or nutritional advice, and cooking meals — all life-flows that can feed into a healthy lifestyle or medically-tailored support at home. As a connected health device, Abbott’s FreeStyle Libre 3, and.

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Telemedicine FDA Nurses Doctors 174

Healthcare Law Blog

MARCH 17, 2022

22-05 , relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). Medical device manufacturers should pay close attention to this trend when considering trial designs and patient populations.

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US Department of Health and Human Services Informed Consent Medicare Medicare 52

HIT Consultant

OCTOBER 14, 2021

Food and Drug Administration (FDA) clearance for the Prenosis Sepsis Immunoscore™ and the Roche Elecsys® IL-6 Assay. ” The Sepsis ImmunoScore™ is an Artificial Intelligence/Machine Learning (AI/ML) Software as a Medical Device (SaMD) that Prenosis intends to submit to the FDA for clearance by the end of the year.

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Hospitals Electronic Medical Records COVID-19 FDA 98

Health Populi

JANUARY 31, 2018

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. Omron seeks to jump that hurdle through FDA clearance. Stroke accounts for 1 in 20 deaths in the U.S., according to the CDC.

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FDA Doctors Public Health Medicare 81

Health Populi

JANUARY 7, 2019

Self-care is the new health care as patients, now consumers at greater financial risk for medical spending, are learning. At #CES2019, I’m on the lookout for digital technologies that can help people adopt and sustain healthy behaviors that can help consumers save money on medical care and enhance quality of life-years.

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FDA Patient Advocacy Medicare Medicare 67

Healthcare IT Today

AUGUST 15, 2023

The company has built a comprehensive portfolio of stroke solutions, including Rapid NCCT Stroke – the first and only FDA-cleared medical device to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from non-contrast CT imaging.

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FDA Hospitals 52

HIT Consultant

DECEMBER 20, 2022

In August, the Food and Drug Administration established a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.

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FDA 98

SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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US Department of Health and Human Services FDA COVID-19 World Health 40

Health Populi

JULY 28, 2020

Twelve years ago, when I began to attend CES, digital health was a nascent category featured with products featured in a couple of aisles in exhibit booths then dominated by Fitbit, Nike and UnderArmour. The company’s Core ScanWatch was a CES 2020 Honoree in the category of Fitness/Sports and Wearable Technologies.

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Public Health COVID-19 Telemedicine FDA 116