Bill of Health

JANUARY 28, 2022

Food and Drug Administration (FDA), under which the agency does “not consider it appropriate to add vitamins and minerals to alcoholic beverages.” FDA similarly discourages companies from fortifying snack foods to avoid misleading consumers about their health value. But what about that FDA policy on fortification?

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FDA Public Health 162

Bill of Health

FEBRUARY 18, 2022

Trade secrets, on the other hand, are, by definition, much more ambiguous. Food and Drug Administration (FDA). In contrast, for small molecule drugs, in 2019 alone the FDA approved nearly 1,000 generic drug applications. This means the patent holder must only disclose the minimum steps for the end product to be produced.

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FDA 208

Bill of Health

MARCH 4, 2024

With this, we’re seeing active lobbying from stakeholders in the psychedelic realm on everything from telehealth to “psychedelic” definitions to research guidelines. But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy. MDMA-assisted therapy”).

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FDA Governance 140

Mobi Health News

SEPTEMBER 26, 2019

The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.

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FDA Compliance 80

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Bill of Health

SEPTEMBER 21, 2024

Food and Drug Administration (FDA), and Department of Health Human Services (HHS). It may very well be that deciding when an alpha amino acid polymer is a “protein” to be regulated by the FDA is not simply a question of statutory interpretation, but also a question of science and policy. Loper Bright overturned Chevron v.

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FDA ACA Governance 124

C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

FDA 52

FDA Licensing Public Health 52

Health Law Advisor

MAY 19, 2022

The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% 9-THC concentration of not more than 0.3 Fighting Cancer. ? The result?

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FDA Hospitals 52

HIPAA Journal

MARCH 4, 2022

The Pyxis Security Module for automated patching and virus definition management is provided to all accounts. Users should work with their BD support team to ensure all patching and virus definitions are up to date. “BD BD self-reported the vulnerabilities to the FDA, ISAOs, and CISA for maximum awareness.

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FDA HIPAA 124

Health Law Advisor

SEPTEMBER 12, 2023

The DEA has the final authority to reschedule a drug and will now initiate its own review of marijuana, a process that does not have any definitive timeline but could be moved along if determined to be an agency priority. In addition, only certain components of FDA’s eight-factor analysis bind the DEA. heroin, LSD, and ecstasy).

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FDA Licensing Public Health 111

Healthcare IT Today

FEBRUARY 11, 2021

I’ll be the first to admit that I didn’t know the history of the stethoscope and definitely didn’t understand how it worked. Although, we certainly all know how iconic the stethoscope is in healthcare. It’s been a fixture in medicine that hasn’t really been innovated on in years. At least until now.

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FDA Telemedicine 133

Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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FDA Compliance Regulatory Compliance 52

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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FDA Governance 52

Hall Render

JANUARY 14, 2025

Food and Drug Administration (“FDA” or “Agency”) published a final rule updating the criteria for the implied nutrient content claim healthy that appears on food packaging. Interestingly, the updated definition now allows for the inclusion of foods previously excluded. On December 27, 2024, the U.S. Modern U.S.

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FDA 40

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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FDA Informed Consent 52

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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FDA Medical Device Industry Doctors Regulatory Compliance 52

Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. So, there are two parts to the definition of these devices – what they are and how they are used.

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COVID-19 FDA Medical Device Industry Public Health 52

NEJM

DECEMBER 22, 2021

The FDA has long taken the legal position that regulated devices could also be categorized as drugs. But according to a recent case, products meeting the definition of a device “must be regulated as devices.” The decision comes amid growing challenges to FDA authority.

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FDA 40

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.

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FDA Compliance Public Health 40

Health Populi

OCTOBER 6, 2021

Or an expanded definition of a “digital therapeutic” with the car as a delivery channel or vessel for care and information source. That a pharmaceutical company executive is speaking on the main stage at CES speaks to the category’s mainstreaming beyond elite athletes and smartwatches that track activity.

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COVID-19 FDA Health Outcomes Doctors 147

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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Informed Consent FDA Public Health World Health 130

Health Law Advisor

DECEMBER 6, 2022

I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. For context, I should explain that I didn’t set out to find differences in the FDA data sets. I don’t know why, and frankly I hope the FDA changes that. Background.

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FDA 98

HIT Consultant

JANUARY 12, 2024

The APS200 Duo includes a wide-angle camera for remote patient observation and a high-definition 40x power zoom camera for virtual nursing programs and remote patient examinations. These FDA-registered Class 1 medical devices can integrate with digital TVs and Interactive Patient Console systems, optimizing space.

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Nurses FDA Hospitals 96

Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

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FDA 52

Healthcare IT Today

JUNE 27, 2023

Food and Drug Administration (FDA) has recognized the problem and issued multiple guidance documents over the years—as recently as this March —to ensure the cybersecurity of medical devices. Although none of the FDA recommendations are legally enforceable, device manufacturers no longer have a choice but to comply.

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Ransomware FDA Governance Hospitals 114

Health Populi

DECEMBER 27, 2021

Or an expanded definition of a “digital therapeutic” with the car as a delivery channel or vessel for care and information source. That a pharmaceutical company executive is speaking on the main stage at CES speaks to digital health’s mainstreaming beyond elite athletes and smartwatches that track activity.

COVID-19 162

COVID-19 FDA Health Outcomes Doctors 162

Health Law Advisor

SEPTEMBER 5, 2023

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. 70% seems to be a sort of floor to what FDA will consider.

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FDA 111

Healthcare IT Today

JUNE 7, 2023

DSI and Predictive Models ONC is clearly attempting to leverage its certification program to help the Food and Drug Administration (FDA) increase transparency related to decision alerts, but this seems to be an inefficient and burdensome application of the certification lever.

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FDA Compliance Regulatory Compliance Medicaid 97

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”). Specifically, the definition of IVD in 21 C.F.R.

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FDA Public Health Compliance Hospitals 40

HIT Consultant

APRIL 2, 2024

What You Should Know: – Eko Health , a provider of AI-powered heart and lung disease detection today announced FDA clearance for its Low EF detection AI. When the AI detects Low EF during a primary care exam, patients can be promptly referred to cardiology for definitive diagnosis and treatment planning.

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FDA Health Outcomes 40

Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. The lawsuit alleged that the device was not approved or authorized by the FDA and that the procedure was not covered by Medicare. The FDA has jurisdiction to regulate products that meet the definition of “device” under section 201(h) of the FDCA.

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FDA Governance Medicare Medicare 59

Healthcare IT Today

SEPTEMBER 3, 2023

The American Telemedicine Association published Health Data Privacy Principles , paying particular attention to consistency in regulations, definitions of consumer health, consumer consent, and legal enforcement. Sales Banner Health chose nference for biomedical data analysis.

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FDA Telemedicine Health Insurance Hospitals 94

The Digital Health Corner

JUNE 14, 2017

One early definition of Artificial Intelligence (AI) in medicine (1984) was “…the construction of AI programs that perform diagnosis and make therapy recommendations. Today a broader definition may be applied: “the simulation of human intelligence processes by machines, especially computer systems. in the approval process of drugs.

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Patient Satisfaction Hospitals FDA Governance 87

HIPAA Journal

NOVEMBER 4, 2022

The Department of Health and Human Services (HHS) is the Sector Risk Management Agency (SRMA) for the healthcare industry, but within the HHS agencies such as the Office for Civil Rights (OCR), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA) have their own jurisdictions and cybersecurity policies.

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HIPAA Governance FDA Medicaid 134