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 FDA regulates the sale of all medical device products, including personal health devices that transmit data to AI-driven healthcare solutions as described above.

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Healthcare Law Blog

MARCH 17, 2022

The three-component Therapy includes the following: (1) a device to process patient bone marrow (after an extraction procedure); (2) a device to re-inject processed bone marrow into cardiac tissue; and (3) an FDA-approved guide catheter to facilitate placement of processed bone marrow into cardiac issue.

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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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Health Populi

JANUARY 11, 2019

Federal government shutdown. Who will spend over $99 for an FDA-cleared medical device for home use? It is encouraging to see the growing health and fitness supply side at CES populated with more products that have been FDA-cleared for serious clinical use.

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Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. The sectorialism of the U.S.

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Bill of Health

OCTOBER 5, 2023

Federal, state, and municipal governments have taken steps towards halting the use of racially biased health care algorithms, but more comprehensive regulation and oversight is needed. Food and Drug Administration (FDA) has also begun to consider the regulation of clinical algorithms.

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Health Populi

JUNE 20, 2019

Note that the findings on how people know they are eating well fall into four categories: health, enjoyment, mindfulness, and their budget. Intriguingly, government agencies tie at one in five people for both being on my side and working against me. Health benefits are sought by 6 in 10 people.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Jane Sarashon

JULY 29, 2022

Power’s top customer satisfactoin rank in the brick-and-mortar supermarket pharmacy category, noted for the grocer’s high Net Promoter Score for customer loyalty. government would have saved $2.6 For the second year in a row, H-E-B received J.D. billion in 2018. Costco isn’t only beloved for the $1.50

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Bill of Health

SEPTEMBER 28, 2023

Such a provision could prevent the public from paying twice for publicly-funded medical products—first through their taxes subsidizing government funded research and development, and second to procure the product in an inflated U.S. pharmaceutical market.

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SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

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Healthcare It News

FEBRUARY 20, 2024

Challenges in diagnosing sleep apnea and research that shows positive airway pressure treatment can lower healthcare costs motivate healthcare organizations and government agencies like the U.S. New FDA update on Philips Respironics' 2021 device recalls PAP machines which deliver oxygen through a mask, are one way to treat sleep apnea.

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HIT Consultant

JUNE 29, 2023

The community category included ambassador programs and work with community advisors. It begs the question: how do we ultimately achieve full representation and ensure accountability to uphold the promises we have made for patients?

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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HIT Consultant

MARCH 15, 2022

These digital phenotyping solutions have been adopted by health organizations, tech, commercial and government entities. Food & Drug Administration (FDA), paving the way for widespread deployment across healthcare systems in the USA. Philips Capsule Surveillance receives 510(k) clearance.

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Health Law Advisor

APRIL 5, 2022

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”

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Hall Render

MARCH 25, 2022

FDA to revive facility visits. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. Federal government investigating over 2 dozen ‘major’ medical data breaches in the Carolinas. Report moves South Carolina’s health disaster preparedness from ‘low’ to ‘high’ category. NORTH DAKOTA.

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SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). United States Food and Drug Administration (FDA) – Regulations and Guidances. .” instead of BTNX Inc.

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

Kaiser Health News

MAY 13, 2022

The period-tracking app Cycles, which is owned by Swedish company Perigee, falls into this category. Data brokers trade in other types of information, such as location-tracking data for people who visited Planned Parenthood, which potentially could be purchased by law enforcement or government officials. “The U.S.

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US Department of Health and Human Services HIPAA Governance Health Insurance 101

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

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Health Law Advisor

JULY 21, 2023

Food and Drug Administration (FDA) as breakthrough devices. [1] 5] However, devices in earlier stages of the FDA approval process often lack the clinical evidence needed to satisfy the “reasonable and necessary” criteria to justify CMS’s establishment of a national coverage standard.

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Health Populi

AUGUST 3, 2018

adults favor having the FDA approve more generic, over-the-counter (non-prescription, or switched Rx’s), and biosimilar drugs to encourage more competition. This is often the scenario when an Rx has moved to the generic Tier 1 category on a PBM formulary. Check out the table’s third row: overall, 2 in 3 U.S.

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Prescription Drug Pricing FDA Public Health Medicare 67

Health Populi

FEBRUARY 4, 2020

Whether Democrat, Independent, or Republican, most people living in America favor government intervention in regulating the cost of medicines in some way. CMO Sumit Dutta introduces the report with the following proviso: “We look at several drugs expected to be approved by the FDA in the months ahead. Few issues unite U.S.

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Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

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US Department of Health and Human Services FDA Medicare Medicare 52

Health Populi

DECEMBER 25, 2018

This bill would create a government-run drug company to produce and distribute generic medicines. Digital health literacy, greater adoption of wearable tech and tracking apps, FDA-cleared devices that measure medical metrics like heart function, and people going online to sign up for health insurance.

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Kaiser Health News

FEBRUARY 9, 2023

Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. Rovner: Sarah, is the FDA worried about this case? So it’s a semantics game, in part. It’s very chaotic.

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US Department of Health and Human Services Medicare Medicare FDA 52

Drug & Device Law

APRIL 28, 2022

State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations. Whereas those jurists who otherwise tout the importance of civil rights in our legal system may be inclined to afford local governments more deference in restricting speech.

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. The rulemaking process governing monographs was replaced with an administrative order process. Levine , 555 U.S. 2022 WL 17348351, at *4. Albrecht , 139 S.

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Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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Compliance FDA Governance State Policy 52

Drug & Device Law

SEPTEMBER 14, 2023

1, 2023), which concerned an APA-based challenge to FDA public statements on the use of ivermectin to treat or prevent COVID-19 in humans. Over the last three years or so, we have written plenty on ivermectin , hydroxychloroquine , and government measures to combat the COVID-19 pandemic. Phrased too broadly, “FDA is not a physician.

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Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our What risk is acceptable for a device in a high risk category (i.e., Plaintiff also offered a claim based directly on failure to report adverse events to FDA.

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FDA Fraud Doctors Public Health 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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Drug & Device Law

MAY 12, 2023

But the plaintiffs/appellants disclaimed the intelligence to understand the relationship between serving size and calorie count and asked the court to require the spray’s manufacturer to slather on far more label information than the FDA required. The claims were preempted, of course. But we get ahead of ourselves.

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Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events.

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