Healthcare IT News - Telehealth

AUGUST 19, 2020

"Using a patient service coordinator to schedule and contact patients to gain necessary paperwork and payments proved to be an effective workflow. In 2017, AccessHealth set goals that were modeled after the Department of Health and Human Service’s Healthy People 2020 Program. USING FCC AWARD FUNDS.

COVID-19 171

COVID-19 Telemedicine Compliance HIPAA 171

Dot Compliance

DECEMBER 7, 2022

Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. A quality management system (QMS) is a codified system (paper or software-based) for documenting roles, processes, and procedures to develop goods that comply with FDA, ISO, EU MDR, and other regulatory standards as well as client expectations. The Bottom Line. QMS Timeline.

FDA 52

FDA Compliance Records Management 52

SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

FDA 52

FDA Compliance Public Health Hospitals 52

Innovaare Compliance

MARCH 1, 2022

Since 2017, benchmarks have been rising and in 2019, Medicare spent $321 more per person for MA enrollees than it would have spent for the same beneficiaries under traditional Medicare fee-for-service (FFS). 3] The bid is prepared from credible baseline pricing data.

Medicare 52

Medicare Medicare Overpayments Overpayment 52

SQA

DECEMBER 16, 2022

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. Applicants and MAHs can contact EMA via rawdatapilot@ema.europa.eu United States Food and Drug Administration (FDA) – Regulations and guidance. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

FDA 40

FDA Licensing Governance Compliance 40

HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production. million Americans.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals FDA Telemedicine 96

Healthcare Law Blog

OCTOBER 25, 2023

Effective July 1, 2017, the Chicago Municipal Code requires that an individual who markets or promotes pharmaceuticals to HCPs within the City of Chicago for more than 15 calendar days during the year must have a license from the City of Chicago’s Department of Business Affairs and Consumer Protection. 2017 Nevada Laws Ch. ix] Nevada.

Licensing 52

Licensing Compliance FDA Public Health 52

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. Omicron amplifies hospital staffing shortages, contact tracing challenges. Ohio Department of Health says schools can discontinue universal contact tracing.

Nursing Homes 40

Nursing Homes COVID-19 US Department of Health and Human Services Nurses 40

HIT Consultant

JANUARY 16, 2023

As more digital medication management solutions gain FDA approval, there is an increased opportunity to integrate digital support as part of the medication process and reduce medication abandon rates. Anish Sebastion, CEO and Co-founder of Babyscripts.

Nurses 98

Nurses FDA Health Insurance Overpayments 98

Drug & Device Law

MARCH 2, 2023

Walden focused the need for a claim-by-claim analysis of the relationship between the allegedly actionable conduct and the defendant’s contact with the state seeking to exercise personal jurisdiction over it. The Supreme Court pretty much put the kibosh on this in 2017 in its Bristol-Myers Squibb decision. 2023 WL 2111346, *6.

FDA 59

FDA Public Health 59

Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

FDA 52

FDA Fraud Doctors Governance 52

Drug & Device Law

APRIL 17, 2023

22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal. Plaintiff alleges that information from the “FAERS Public Dashboard” and clinicaltrials.gov, which are maintained by the FDA. . . . Bristol-Myers Squibb Co. 2022 WL 3012519 (C.D. His second try wasn’t any better than the first. emphasis added).

FDA 59

FDA Doctors 59

Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement. Alcon Laboratories, Inc. 2024 Ohio Misc.

FDA 52

FDA Fraud Doctors 52