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

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

Health Populi

FEBRUARY 4, 2019

The report’s insights are based on surveys FMI has conducted over the past two years, as the Foundation has observed that consumers broadening their definition of health to include emotional health, energy levels, and sleep quality.

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Doctors Nurses Public Health Medical Billing 123

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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

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FDA HIPAA Compliance 60

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

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 157

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

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

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

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 65

HIT Consultant

OCTOBER 30, 2023

announced today a definitive agreement for United Therapeutics to acquire Miromatrix for $91M. United Therapeutics is a biotechnology company with six FDA-approved therapies to address rare, life-threatening conditions, and a pipeline that includes four ongoing registration-phase studies.

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FDA 52

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

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 RX

FEBRUARY 13, 2023

Section 1461 is among the statutes listed in the definition of “racketeering activity.” 18 U.S.C. §§ 1961 et seq. Therefore, the warning letters highlight that a violation of § 1461 could give rise to civil liability under RICO. See 18 U.S.C. 1962 (a)-(d).

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FDA 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 113

HIT Consultant

JULY 21, 2023

The investment comes at a pivotal time in the advancement of Alzheimer’s disease treatments, with Biogen and Eisai’s Lecanemab (LEQEMBI®) recently receiving traditional FDA approval, ushering in a new era for the next generation of Alzheimer’s treatments.

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FDA 52

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 78

Bill of Health

MAY 8, 2023

FDA , Judge Matthew Kacsmaryk uses the words “unborn human” and “unborn child” throughout the opinion to describe a fetus. Yet, practices in ART such as selective reduction would meet the definition of abortion in many states. Lower courts are already off to the races attempting to ascribe personhood to fetuses.

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Doctors FDA 233

Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. Not to spill the beans, but if you think that, you’d be wrong.

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FDA Compliance 52

Jane Sarashon

MAY 22, 2023

“It seemed like an odd pairing: shampoo and a throat swab,” observes a new report on the growth of retail health from Definitive Healthcare. While the use of emergency departments fell by 1% in the past five years, the use of retail clinics expanded by 70%, Definitive Healthcare calculated.

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Patient Advocacy FDA Hospitals Doctors 52

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 126

Dot Compliance

APRIL 12, 2022

The FDA definition of a medical device is something that diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body. US FDA Requirements. Additionally, the FDA requires medical device manufacturers to use Unique Device Identification labels.

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FDA Compliance Regulatory Compliance 52

CMS.gov

SEPTEMBER 13, 2021

In January 2021, we published a final rule called The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ (MCIT/R&N). Food & Drug Administration (FDA)-designated breakthrough device once the device received or cleared market authorization.

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Medicare Medicare FDA Medicaid 37

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 106

Dot Compliance

SEPTEMBER 30, 2022

It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. It depends on other accepted standards for its definition, application, and actual execution. For cGMP compliance, the FDA audits authorized drug manufacturers.

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FDA Pharmaceutical Industry Compliance 52

Dot Compliance

FEBRUARY 8, 2022

A comprehensive definition of SaMD comes from the International Medical Device Regulators Forum (IMDRF) , the group of global medical device regulators charged with harmonizing the regulatory requirements of different medical products from different countries. What is Software as a Medical Device (SaMD)?

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FDA Compliance 52

Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

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Compliance HIPAA FDA Due Diligence 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 141

Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. If the answer is yes, then FDA may not issue an EUA.

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FDA COVID-19 US Department of Health and Human Services Public Health 52

Healthcare IT Today

NOVEMBER 12, 2023

News The 2024 Medicare Physician Fee Schedule continues many telehealth flexibilities first adopted during the public health emergency, such as an expanded scope of originating sites an expanded definition of qualified practitioners. RapidAI received FDA clearance for Rapid SDH , which helps to detect bleeding in the brain.

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Payment Systems Public Health Medicare Medicare 110

Healthcare IT Today

OCTOBER 6, 2023

We have definitely seen a greater mix of revenue growth from cross-selling in recent quarters. For example, the FDA has approved more than 350 medical devices enabled by artificial intelligence and machine learning – most of which are being used for medical image analysis.

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FDA Hospitals 66

HIT Consultant

MAY 2, 2022

The FDA is attempting to address this, having issued guidelines related to diversity in clinical trials in November 2020 – perhaps prompted by widespread media coverage of the fact that the black members of the society and other people of color were underrepresented in clinical trials for COVID-19 vaccines.

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COVID-19 Vaccine Patient Advocacy Pharmaceutical Industry COVID-19 98

Compliance Now

AUGUST 1, 2022

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. Medical management is only permitted if multiple, substantially similar services or products are available. Imposing an age limit on contraceptive coverage. Specific Required Benefits.

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FDA Medicare Medicare Governance 100