Health Law Advisor

MARCH 7, 2023

The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Bill of Health

NOVEMBER 30, 2022

Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. State pharmaceutical bans and restrictions — which are often medically unnecessary and instead based largely on policymakers’ moral and political views — impede the FDA’s mandate to protect and promote the public health.

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FDA Bioethics Public Health Governance 176

HIT Consultant

JANUARY 25, 2022

Following the FDA ruling to authorize the emergency use of PAXLOVIDTM, Alpha providers are now able to prescribe COVID-19 treatment when appropriate, to a patient’s local pharmacy through their asynchronous telemedicine platform. Why It Matters.

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COVID-19 Telemedicine FDA Doctors 52

Healthcare IT News - Telehealth

JANUARY 19, 2021

At the second installment of the American Telemedicine Association's EDGE policy conference on Tuesday, leaders in the healthcare space reiterated the importance of cybersecurity as a patient safety issue. "FDA does not regulate telemedicine," she reminded co-panelists. "The key here is going to be people.

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Telemedicine Ransomware FDA COVID-19 216

Healthcare IT Today

FEBRUARY 25, 2024

Roughly 83% of clinicians agree that telemedicine is effective for managing chronic conditions , according to a SteadyMD survey. X-trodes receives FDA 510(k) clearance for Smart Skin , its wireless wearable for monitoring brain, heart, eye, and muscle activity.

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Telemedicine Compliance FDA Hospitals 89

Healthcare IT Today

FEBRUARY 12, 2024

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive.

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Doctors FDA Telemedicine HIPAA 92

Mobi Health News

AUGUST 20, 2021

Also, Ujala Cygnus opens an ICU telemedicine facility in New Delhi.

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FDA Telemedicine 98

Mobi Health News

JULY 17, 2019

The suit alleges that only three of the nine STD tests sold by WebMD have undergone FDA approval process.

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Telemedicine FDA 76

HIT Consultant

AUGUST 16, 2021

What You Should Know: – Eko , a cardiopulmonary digital health company launches its next-generation Eko DUO, an FDA-cleared cardiac assessment tool that functions as an electrocardiogram (ECG) and digital stethoscope to detect early signs of heart disease and facilitate timely care and personalized disease management.

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FDA Telemedicine HIPAA 98

Healthcare IT News - Telehealth

MARCH 14, 2022

Virtual-reality telemedicine. The bundle includes the VIVE Flow immersive glasses, preloaded with XRHealth FDA-registered medical applications, and includes a screening video call with an XRHealth clinician. Individual patients can purchase "Flow Health" for $599.

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FDA Doctors Telemedicine Health Outcomes 146

Verisys

DECEMBER 12, 2023

US S3193 DEA: The DEA and Department of Health and Human Services (HHS) has announced the extension of current telemedicine flexibilities through December 31, 2024. In particular, practitioners are allowed to prescribe controlled medications via telemedicine, even when the practitioner has not conducted an in-person evaluation.

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

HealthIT Answers

NOVEMBER 1, 2023

News from Iris Telehealth, Caregility, Amazon Clinic, GNC, American Hospital Association, TytoCare, Amwell, 19Labs, Teladoc Health, Evernorth, MDLIIVE, DocVilla, FDA, InfoBionic, and more. We are seeking out the latest developments around virtual healthcare. The post Virtual Healthcare November 2023 appeared first on Health IT Answers.

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FDA Hospitals Telemedicine 64

Mobi Health News

JANUARY 2, 2020

Also: Travel medicine company launches telemedicine offering for low-cost international care.

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FDA Telemedicine 60

Healthcare IT Today

AUGUST 28, 2023

Mimi Winsberg, Co-Founder and Chief Medical Officer at Brightside Health We have been in an uncertain time for regulation around telemedicine, and there are a few key trends to watch. We need to refine the Ryan Haight Act to develop a telemedicine registry that can safely prescribe controlled medication virtually.

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US Department of Health and Human Services Telemedicine Hospitals Compliance 112

Healthcare IT News - Telehealth

APRIL 11, 2023

" Joe Tracy, Lehigh Valley Health Network Having done this work for nearly 30 years, Tracy does not think of the technology as “telemedicine technology.” ” Rather, he said it consists of telecommunication technologies, coupled in some instances with FDA-approved medical instruments.

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Nurses Telemedicine FDA Hospitals 154

HIT Consultant

JUNE 30, 2022

The use of wearables during the COVID-19 pandemic increased dramatically, helping cardiologists to extend the use of the patient’s own wearable solutions during telemedicine consultations to help whilst inpatient visits were limited. Apple subsequently gained approval for its 2.0 Apple subsequently gained approval for its 2.0

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COVID-19 FDA Telemedicine Hospitals 97

Mobi Health News

OCTOBER 1, 2019

Also: ResApp announces results of prospective study on obstructive sleep apnea; Cosnumer telemedicine company Hims opens pharmacy operation in Columbus, Ohio.

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Telemedicine FDA 55

Healthcare IT Today

JANUARY 24, 2024

They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful. Of course, these companies can’t say this is what they’re able to do until they get FDA clearance, but the early results seem promising. Here’s a look at how their demo worked for me.

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FDA Doctors Licensing Telemedicine 120

Healthcare IT News - Telehealth

MAY 9, 2022

In the wake of the news, several companies that offer abortion via telemedicine say they've seen a surge of interest in their services. In December 2021, the FDA opted to permanently modify its regulations, thereby enabling abortion via telehealth in more than half the country. " Black women were 2.5 THE LARGER TREND.

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COVID-19 FDA Telemedicine Hospitals 160

Healthcare IT News - Telehealth

JULY 16, 2020

Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. Of course, the ruling doesn't remove all barriers to abortion via telemedicine. " Yeh, who practices in Seattle, said telemedicine itself has its hurdles. Louis Region and Southwest Missouri.

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COVID-19 Telemedicine FDA Public Health 172

Healthcare IT News - Telehealth

JULY 25, 2023

Pager offers AI automation and integrated concierge services, including triage, telemedicine, e-prescriptions, appointment scheduling, after-care follow-up, care advocacy and customer service. The company noted it has tested more than half the population of England and is the largest provider of remote sexual health testing across Europe.

Public Health 111

Public Health COVID-19 FDA Telemedicine 111

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. Cybersecurity Reports More than 60% of cybersecurity incidents adversely impact patient care , a study from Claroty said.

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FDA Telemedicine Health Insurance Hospitals 106

Healthcare IT Today

JANUARY 11, 2024

Almost all of their new devices are regulated by the FDA as medical devices. .” The impact can be widespread, because only 16% of people with diabetes get their annual foot exam, but the scale can identify problems with their feet early. But Robiliard says that need more studies to demonstrate ultimate impact on the patient.

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FDA Doctors Hospitals Telemedicine 100

Healthcare IT News - Telehealth

FEBRUARY 6, 2024

"The focus of our session is how technology enables and enhances clinical workflows and patient experiences and outcomes, especially when applied to an emerging area of telemedicine like remote patient monitoring," he explained.

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Nurses FDA Telemedicine Health Outcomes 159

HealthIT Answers

JANUARY 10, 2023

The FDA established the Office of Digital Transformation in September 2021. By Vid Desai & Jessica N. Berrellez - Digital transformation is a continuous journey that touches every part of an organization. The post Office of Digital Transformation’s New Focus on Technology Leadership appeared first on Health IT Answers.

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FDA Telemedicine 52

Healthcare IT Today

MAY 25, 2022

With COVID-19 infections and hospitalizations rising, the FDA approved two drugs—Paxlovid from Pfizer, and molnupiravir from Merck and Ridgeback—to treat the illness that is killing so many and rendering others permanently disabled. The dilemma is heart-rending.

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COVID-19 FDA Hospitals Telemedicine 86

HIT Consultant

DECEMBER 15, 2021

The ARC Innovation Center focuses on digital health technologies including precision medicine, big data, artificial intelligence (AI), predictive analytics, telemedicine and mobile health. The six companies from Sheba to secure investments in 2021 include: 1.

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FDA Hospitals Telemedicine Licensing 98

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. 18 U.S.C. § Under 21 U.S.C. § 802(54), including circumstances designated by the U.S.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 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

HIT Consultant

APRIL 4, 2023

In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health. Regulatory Developments and Adapting Digital Health Startups If circumstances weren’t treacherous enough, digital health startups are bracing for impending regulatory changes.

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FDA Medicaid Medicaid COVID-19 52

Health Populi

JANUARY 4, 2022

Withings’ FDA-cleared smartwatch as a health/care wearable technology. adults that attended a video meeting did so for medical-related purposes — such as virtual health care, telemedicine, remote monitoring consultation. As a connected health device, Abbott’s FreeStyle Libre 3, and.

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Telemedicine FDA Doctors Nurses 174

Healthcare IT Today

APRIL 14, 2024

CloudWave renewed its partnership with the FDA to share threat intelligence data for medical device security. A CHEST Journal paper found CLEW Medical’s models for predicting patient deterioration are more accurate than those from general-purpose telemedicine systems.

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Nurses HIPAA FDA Telemedicine 103

Healthcare IT Today

MAY 20, 2023

That’s why the Connected Health Initiative advocates on behalf of all health IT vendors on issues ranging from reimbursement to interoperability to FDA regulation, Colin learned in a conversation with CHI’s Brian Scarpelli. Read more… Large Language Models Will Transform Telemedicine.

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Ransomware Telemedicine Public Health FDA 98

Healthcare IT Today

JULY 12, 2023

From telemedicine and AI-enabled devices to integrations with EHRs, data is at the center of it all and needs to be accessible from an uptime, resiliency, and privacy perspective. New technologies such as telemedicine and AI-enabled medical devices require software, computing, and storage.

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Telemedicine FDA World Health Health Outcomes 88

Healthcare IT Today

JANUARY 14, 2024

Infant monitoring company Owlet launched two FDA-cleared devices : Dream Sock and BabySat. Product and Company News from JPM 2024 Butterfly Network received FDA clearance for Butterfly iQ3 , its point-of-care ultrasound system. The program is supported by funding from the FCC’s Affordable Connectivity Program.

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Medicaid Medicaid FDA Medicare 107

Healthcare IT News - Telehealth

NOVEMBER 7, 2022

Bioflux-AI combines an FDA-approved, high-precision, small mobile cardiac telemetry device with AI-driven algorithms specifically trained for the prediction of stroke in stage 4 and stage 5 chronic kidney disease patients. How important is AI to this type of telemedicine/remote patient monitoring?

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Telemedicine FDA Hospitals 155

Healthcare IT News - Telehealth

MARCH 8, 2022

Telemedicine is at the forefront of discussion around COVID and it was a great tool to deal with episodic care during the pandemic, reducing the number of patients frequenting providers. The FDA quickly recognized how critical this would be when they issued a remote patient monitoring enforcement policy in 2020.

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COVID-19 Telemedicine Hospitals FDA 177