Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

Informed Consent 52

Informed Consent FDA 52

Sharps Compliance

MAY 11, 2022

Between 2010 and 2018, there were 48,000 accidental prescription opioid exposures among young children.3. Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog.

FDA 82

FDA Compliance 82

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.

FDA 97

FDA Ransomware HIPAA Hospitals 97

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. ?

FDA 52

FDA Hospitals 52

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.

FDA 70

FDA 70

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. Below are some highlights from the Final Guidance.

FDA 40

FDA Compliance Public Health 40

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.

FDA 98

FDA Public Health Medicare Fraud 98

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 113

FDA HIPAA Compliance 113

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.

FDA 52

FDA Governance 52

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.

FDA 148

FDA Hospitals 148

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!

FDA 52

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.

FDA 52

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.

FDA 87

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.

FDA 80

FDA 80

Mobi Health News

SEPTEMBER 12, 2018

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

FDA 110

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.

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

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 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.

Fraud 94

Fraud Health Outcomes FDA 94

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.

FDA 209

FDA COVID-19 Medicaid Medicaid 209

Mobi Health News

DECEMBER 21, 2018

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

FDA 78

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.

FDA 280

FDA COVID-19 Vaccine Public Health COVID-19 280

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.

Bioethics 148

Bioethics COVID-19 FDA 148

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.

Medicare 148

Medicare Medicare Medicaid Medicaid 148

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.

FDA 85

FDA 85

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.

FDA 52

FDA Compliance Regulations Compliance 52

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.

FDA 89

FDA 89

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.

FDA 117

FDA Doctors 117

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.

Health Insurance 209

Health Insurance Hospitals FDA Medicaid 209

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.

FDA 96

FDA COVID-19 Doctors Compliance 96

Mobi Health News

DECEMBER 21, 2018

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

FDA 40

FDA 40

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

FDA 98

FDA Compliance 98

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.

Hospitals 98

Hospitals FDA Compliance COVID-19 98

Healthcare Law Blog

AUGUST 3, 2022

Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The FDA approved the probe for single-person use, but Prometheus allegedly trained providers to reuse the device on multiple patients by covering the probe with a glove or condom.

Governance 52

Governance FDA Medicare Medicare 52

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.”

Overpayments 154

Overpayments Overpayment Medicare Medicare 154

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.

FDA 98

FDA Health Outcomes Doctors Hospitals 98