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. ?

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. For example, in furtherance of the laudable goal of enhancing access and affordability of hearing healthcare, the FDA does not require that a hearing health professional verify a member’s hearing loss to be eligible for an OTC device. Introducing OTC hearing aids.

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HIPAA Journal

NOVEMBER 16, 2022

healthcare organizations, the Food and Drug Administration (FDA) asked MITRE to develop a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook to help hospitals and healthcare delivery organizations (HDOs) develop a cybersecurity preparedness and response framework.

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FDA Ransomware HIPAA Hospitals 84

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Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.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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Mobi Health News

APRIL 6, 2018

In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.

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FDA 64

Bill of Health

JUNE 20, 2023

Melflufen: post-hoc subgroup analyses and the US FDA Oncologic Drugs Advisory Committee. Physician Perspectives on FDA’s Decision to Grant Accelerated Approval to Aducanumab for Alzheimer’s Disease. Cliff ERS, Janakiram M, Kesselheim AS. Lancet Haematol. 2023 May;10(5):e314-e317. Michaeli T, Jürges H, Michaeli DT.

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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). 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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Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. According to a 2018 Deloitte Consulting report, the market for interconnected medical devices is expected to grow from $15 billion in 2017 to $52 billion by 2025. Medical device industry is changing fast!

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FDA Medical Device Industry Doctors Regulatory Compliance 52

Exeed Regulatory Compliance

FEBRUARY 25, 2020

According to a 2018 report from Deloitte , the IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022. Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification.

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FDA 52

The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

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FDA Compliance Officers Compliance HIPAA 87

Mobi Health News

AUGUST 23, 2022

Formerly known as IDx, the company received FDA De Novo clearance in 2018 for its IDx-DR system used to detect diabetic retinopathy.

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FDA 79

Mobi Health News

SEPTEMBER 12, 2018

A collection of 29 approvals and clearances by the US Food and Drug Administration include several novel products.

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FDA 110

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.

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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.

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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.

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FDA HIPAA Compliance 60

Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. Epub ahead of print. PMID: 35201276.

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Mobi Health News

DECEMBER 21, 2018

The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.

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FDA 78

Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.

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FDA COVID-19 Vaccine Public Health COVID-19 274

Health Populi

MAY 29, 2018

Trust has become a key currency in provider/patient/supplier relationships: 94% of health executives say treating customers as partners is important to gain trust, according to the Digital Health Tech Vision 2018 from Accenture. Finally, the Internet of Thinking rounds out Accenture’s five themes in the 2018 Health Tech Vision.

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Fraud Health Outcomes FDA 90

Bill of Health

SEPTEMBER 13, 2023

His current research focuses on tensions between the patent incentive system, the FDA approval process, and insurance carriers. In the past, Adithi also published work on representation of the Global South and equitable authorship in global health scholarship (The Lancet Global Health, Jan. Vincent Joralemon is a law student (J.D.

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Bioethics COVID-19 FDA 144

Bill of Health

MARCH 24, 2023

US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. JAMA Intern Med. 2023 Feb 13:e226444. Epub ahead of print. Naci H, Forrest R, Zhai M, Stofesky AR, Kesselheim AS.

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Medicare Medicare Medicaid Medicaid 144

Healthcare IT Today

MARCH 29, 2024

Founded in 2018, Overjet has already raised the standard for diagnosing diseases in X-rays, educating patients about their oral health, and reviewing dental insurance claims. Food and Drug Administration (FDA) to detect, outline, and quantify instances of oral disease, with millimeter-level precision.

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American Medical Compliance

OCTOBER 17, 2023

FDA Food Safety Modernization Act (FSMA) The FDA has a legal obligation under FSMA to impose thorough, scientifically based preventative controls on the whole food chain, including obligatory preventive controls for food facilities. Languages: American English Key features: Audio narration, learning activity, and post-assessment.

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FDA Compliance Regulations Compliance 52

Mobi Health News

APRIL 30, 2018

At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.

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FDA 79

Electronic Health Reporter

MAY 1, 2019

In December 2018, the FDA announced its new framework for the real world evidence (RWE) program, which would require including imaging data alongside claims, electronic health records (EHRs) and other datasets in clinical research. This article is copyrighted strictly for Electronic Health Reporter. Illegal copying is prohibited.

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FDA 89

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 Heart Seat has already been tested through multiple peer-reviewed research studies and is currently pursuing FDA clearance.

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FDA COVID-19 Doctors Compliance 96

Bill of Health

MAY 19, 2022

from 2018-2019. Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019. A full posting of abstracts/summaries of these articles may be found on our? Aboy M, Liddell K, Jordan M, Crespo C, Liddicoat J. European patent protection for medical uses of known products and drug repurposing. JAMA Oncol.

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Health Insurance Hospitals FDA Medicaid 205

HIT Consultant

OCTOBER 9, 2022

– The multi-center study evaluated the FDA-cleared EyeArt AI system against dilated eye exams performed by general ophthalmologists and retina specialists on the same cohort of 521 study participants. The study design was a prospective, pivotal, multi-center trial conducted from April 2017 to May 2018. Participants were ?18

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FDA Compliance 98

Mobi Health News

DECEMBER 21, 2018

The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.

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FDA 40

HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. Your FDA 510(k) cleared device must be designed for and evaluated by a number of stakeholders. Carlson joined Immunexpress in 2018 as CEO.

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Hospitals FDA Compliance COVID-19 98

HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. FDA website, December 8, 2017.

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Health Populi

JUNE 5, 2022

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. “Among the 184 most commonly prescribed drugs in Medicare Part D in 2018, 90% could be purchased at Costco for less than $20 for a 30-day supply.”

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Overpayments Overpayment Medicare Medicare 149

HIT Consultant

JUNE 30, 2022

Some core developments from home health solution providers include: AliveCor – AliveCor claims to be the most clinically validated portable ECG solution available and was one of the first vendors to gain FDA approval. Apple subsequently gained approval for its 2.0 Apple subsequently gained approval for its 2.0

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Healthcare IT News - Telehealth

FEBRUARY 6, 2024

"RPM has become more widely used and accepted since the creation of independent billable CPT codes in late 2018, which can be billed independent of home health episodes – normally a bundled payment for all services rendered."

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Nurses FDA Telemedicine Health Outcomes 153

Health Populi

AUGUST 9, 2019

Gallup calls out the 2018 Farm Act which legalized the cultivation of hemp, which is one driving force behind the fast-growing supply side of CBD-based products. Now that I’ve explained the bullish forecast and consumer race to adopt CBD, let’s hear from the FDA which, so far, hasn’t yet issued regulations about CBD.

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FDA 96

Mobi Health News

MARCH 1, 2018

Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.

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