Healthcare IT News - Telehealth

MAY 9, 2022

Between 2017 and 2020, 113 women died from pregnancy-related causes, while 177 deaths during that period were deemed to be "pregnancy-associated." Food and Drug Administration had longstanding policies that required mifepristone, one of the medications used in abortion, to be dispensed at a clinic, hospital or medical office.

COVID-19 164

COVID-19 FDA Telemedicine Hospitals 164

Health Populi

AUGUST 12, 2021

During the pandemic, health care providers needed to deal with the security of devices rapidly procured and deployed within institutions and also outside the walls of providers, such as in field hospitals meeting the surge of coronavirus patients. 32% of medical imaging devices were running on unsupported operating systems, and. billion.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

Healthcare It News

OCTOBER 13, 2021

"In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said. "That same year, FDA approved smart pills. "In the five years since I last talked at CHC, there have been some amazing medical breakthroughs," said Feinberg in his virtual keynote address. That's all noise."

COVID-19 Vaccine 276

COVID-19 Vaccine COVID-19 Doctors Nurses 276

Healthcare IT Today

FEBRUARY 15, 2024

With more than 700 US FDA-approved AI applications, healthcare providers grapple with navigating the complex landscape of niche AI solutions. Today, of the about 700 AI-based applications that are approved by the US FDA, 80% are related to radiology.

FDA 93

FDA Governance Hospitals Health Outcomes 93

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. million Americans.

Pharmaceutical Industry 94

Pharmaceutical Industry Hospitals FDA Telemedicine 94

Health Populi

NOVEMBER 8, 2018

substantially grew between 2012 and 2017, many more women than men use these holistic medicine approaches. In 2017, 14.3% Headspace is a well-adopted app for meditation, getting traction in healthcare with research partners at Carnegie Mellon, Harvard, and Kaiser Permanente who are studying the app to collect data for FDA scrutiny.

FDA 121

FDA Hospitals 121

HIPAA Journal

DECEMBER 8, 2022

The white paper has received considerable praise from industry leaders, with the American Hospital Association and CHIME and AEHIS agreeing with many of the suggestions. The AHA said “hospitals and health systems have prioritized protecting patients and defending their networks from cyberattacks.

HIPAA 106

HIPAA FDA Governance Hospitals 106

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. Software as a Medical Device (SAMD): Clinical Evaluation.

FDA 98

FDA Health Outcomes Doctors Hospitals 98

SQA

AUGUST 2, 2021

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process. ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

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

Healthcare IT News - Telehealth

MARCH 18, 2022

Virtual visits were selected five times more often for anxiety and depression complaints than in-person – and this was for pre-pandemic encounters between 2015 and 2017. Hospitals are faced with impossible decisions. Notably, since 2018, mental health has been the top clinical indication to receive investment, growing from $1.4

Medicaid 205

Medicaid Medicaid COVID-19 Telemedicine 205

HIT Consultant

MAY 9, 2022

From documenting clinical care to filing medical claims and registering patients, paper documents have been entrenched in healthcare processes since the inception of modern hospitals. Billing and claims: Achieving accurate and timely reimbursement is a primary concern for hospital leaders.

FDA 98

FDA COVID-19 Public Health Compliance 98

Health Populi

FEBRUARY 19, 2019

Rock Health has gauged consumes’ digital health adoption fo a few years, showing year-on-year growth for “Googling” health information, seeking peer patients’ physician and hospital reviews, tracking activity, donning wearable tech, and engaging in live telehealth consultations with providers, as the first chart shows.

HIPAA 78

HIPAA Doctors FDA Hospitals 78

Hall Render

MAY 10, 2024

Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M million expansion ‘Very, very unusual.’

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Healthcare IT News - Telehealth

DECEMBER 16, 2020

The pandemic generated uneven experiences for millions of Americans as physicians, therapists, nurse practitioners, hospitals and other caregivers – all coming to telehealth with varying levels of experience themselves – tried suddenly to meet patients where they were, said PwC researchers.

COVID-19 213

COVID-19 Hospitals Doctors Health Insurance 213

HIT Consultant

FEBRUARY 22, 2022

For healthcare consumers, it provides a holistic and comprehensive medical history that is not specific to any healthcare organization or technology and that follows them wherever they go – at a hospital while on vacation, across town to a new provider, or at various specialists. It becomes a tangled web of data points.

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Electronic Medical Records Doctors Hospitals FDA 98

The Digital Health Corner

MARCH 26, 2018

As an implanting and following physician who weathered multiple large and clinically critical recalls and alerts over decades (including ones which changed FDA compliance regulations related to them), I can attest to my own records having been more accurate than those of vendors.

FDA 117

FDA Compliance Medicare Medicare 117

SQA

DECEMBER 10, 2021

The NMPA announcement also identifies several expert groups that will help steer the new authority; these groups will consist of universities, hospitals, healthcare provider networks, life sciences and medical device company representatives, and regulatory agencies. Stage 3: EMA and FDA communicate written responses to the applicant.

FDA 52

FDA Compliance Public Health Hospitals 52

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. times the intended dose and required intervention in a hospital.

FDA 40

FDA Compliance Licensing World Health 40

Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Medicare Medicare 52

Health Populi

OCTOBER 12, 2018

I wrote this post on the deal as an inflection point in American healthcare on 3rd December 2017 when CVS and Aetna announced their marriage intentions. The legacy healthcare system — hospitals, insurance companies, and pharma — haven’t delivered on that expectation. healthcare. healthcare.

US Department of Health and Human Services 58

US Department of Health and Human Services Prescription Drug Pricing Health Insurance Medicare 58

Health Populi

SEPTEMBER 19, 2018

In 2017, 69% of commercially insured patients did not fill a new Rx if there was a $250 out-of-pocket cost. Civica Rx will begin with 14 hospital-administered generic drugs, some of which are in short supply. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs. Thus far, about 500 U.S.

Pharmaceutical Industry 52

Pharmaceutical Industry Hospitals Governance FDA 52

Bill of Health

AUGUST 29, 2022

1] E.g., Anna Edney, Kids’ Covid Hospitalizations Hit Record in U.S. 31, 2021), [link] (describing a record number of pediatric COVID-19 hospitalizations due to the omicron variant). [2] A full form of this Article is forthcoming in the Minnesota Journal of Law & Inequality Vol. Omicron Surge , Bloomberg (Dec.

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Healthcare IT News - Telehealth

AUGUST 19, 2020

In 2017, AccessHealth set goals that were modeled after the Department of Health and Human Service’s Healthy People 2020 Program. As the community’s safety-net healthcare provider, AccessHealth will free up hospitals to focus on COVID-19 patients. The Hemoglobin A1C measure is an important aspect to the quality program.

COVID-19 177

COVID-19 Telemedicine Compliance HIPAA 177

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. In the olden days, before hospitals and doctors’ offices were commonplace, most people were treated by doctors who made house calls.

Nurses 97

Nurses FDA Health Insurance Overpayments 97

Hall Render

APRIL 21, 2023

NATIONAL 6 health systems using GPT and AI tools 100,000 nurses left industry during the pandemic, report finds AHA backs bill to delay Medicaid DSH cuts by 2 years AHA launches info hub for healthcare quality leaders AHA opposes MedPAC recommendations to Congress on site-neutral, Part B drug, wage index policies AHA ramps up 340B protection efforts (..)

US Department of Health and Human Services 40

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

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Healthcare groups urge Congress to extend Acute Hospital Care at Home waiver. Hospital discharge pressures build as nursing homes clamor for help. Hospitals ask Congress to add $25B to relief fund. Rural hospitals seeing staff shortages amid omicron surge.

Nursing Homes 40

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

Health Populi

FEBRUARY 4, 2019

Food stores gained in trust between 2017 and 2018, illustrating the opportunity that a consumer’s favorite grocery store can leverage in a trusted relationship with a person keen on health. Private labels from these stores, and particularly when there’s organic food in the can or package, is a further trust equity factor.

Doctors 123

Doctors Nurses Public Health Medical Billing 123

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. Every time you reduce payment to a drugmaker or a hospital or any other health care provider, that’s a cut, but it helps beneficiaries.

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

SQA

JULY 8, 2022

V60 and V60 Plus devices are designed for in-hospital use. Philips has no permanent solution to correct this issue, so the MHRA is issuing this alert to help hospitals manage the risk. All V680 invasive ventilators used in critical care settings are also affected. This alert should be acted on immediately.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 2017 WL 5617473, at *6-7 (W.D. 21, 2017) (allegation of “no warning” did not preclude the learned intermediary rule); Thompson v. 2017); Money v.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

DECEMBER 12, 2022

Nothing in DeCostanzo suggests that the defendant’s vaccine lacked whatever warnings the FDA had approved, and the likelihood that the FDA would give these antivaxxers the time of day on any violation claim is minimal. Kentucky Fried Chicken , 2017 WL 6416296, at *4 (S.D.N.Y. 300aa-22(b)(1). 300aa-22(c). Wurtzburger v.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 246, 253-54 (2017); Northwest, Inc. 2017), held that a state-law duty to warn a physician “is not synonymous with an affirmative duty to warn a federal regulatory body.” Id.

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Crittenton Hospital , 400 N.W.2d

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

JULY 26, 2023

Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017. So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward. 3d 503, 523 (N.J. Lohr , 518 U.S.

Compliance 52

Compliance FDA Licensing Governance 52

Drug & Device Law

JANUARY 13, 2022

. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports. Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA.

FDA 45

FDA Hospitals 45

Drug & Device Law

SEPTEMBER 9, 2022

470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. The FDA reviewed the notices but did not then have to grant permission before the device could be sold.

FDA 59

FDA Hospitals 59