Connected Health Pulse

MHRA publishes regulatory roadmap for development of medical devices

DigitalHealth

JANUARY 22, 2024

The MHRA has published its regulatory roadmap detailing how new regulations for medical devices are to be rolled out across the UK.

Prior authorization and other regulatory burdens have increased since last year, practices tell MGMA

FierceHealthIT

NOVEMBER 13, 2023

Nine in 10 polled medical practices say their regulatory burden has increased over the past year with prior authorization, audits and appeals, the Medicare Quality Payment Program (QPP) and require | The latest annual poll of practices' regulatory burden outlined prior authorization, audits and appeals, Medicare QPP and other leading pain points (..)

Medicare

Balancing Innovation and Digital Transformation with Regulatory Compliance and Patient Safety

Healthcare IT Today

FEBRUARY 2, 2024

How can professionals in Health IT foster innovation and drive digital transformation within healthcare organizations while balancing the need for regulatory compliance and patient safety ? The need for regulatory compliance and patient safety is not an example of if , it’s a must. This leaves us with one very important question.

Health IT

Health IT Nursing Healthcare IT Healthcare Innovation

HeartBeam Appoints Deborah Castillo as Vice President of Regulatory Affairs

Digital Health Global

AUGUST 8, 2023

Experienced Biomedical Engineer Brings 12+ Years’ Experience in Regulatory Affairs and Quality Assurance for Medical Devices and Diagnostics with FDA and in the Private Sector SANTA CLARA, Calif.–(BUSINESS She is a seasoned regulatory leader with a proven track record of bringing novel medical technologies to market.

Leadership

Leadership Digital Health Medical Technology

The State of Data and Insights in Healthcare Logistics

Amid significant regulatory and compliance changes around the world, they've had to contend with massive supply chain disruptions caused by the pandemic. Medical and pharmaceutical manufacturers have faced increasing logistical challenges over the past two years. Increasing demand for specific products is also causing supply chain shortages.

Pharmaceuticals

Healthcare IT Services and Their Role In 2021 Regulatory Compliance

Electronic Health Reporter

JULY 9, 2021

The article Healthcare IT Services and Their Role In 2021 Regulatory Compliance appeared first on electronichealthreporter.com. Care providers must adhere to the CoP requirements for patient event notifications (ADT Notifications) and the real-time […].

Healthcare IT

Healthcare IT Health Information Interoperability

Reimagining Health Tech on the Cusp of ONC’s Final HTI-1 Rule – Regulatory Talk Series

Healthcare IT Today

NOVEMBER 13, 2023

This article kicks off the Healthcare Regulatory Talk series. For the first time on the federal regulatory stage, the proposed rule brings the concept of algorithmic transparency front and center. This article kicks off the Healthcare Regulatory Talk series. DrFirst is a proud sponsor of Healthcare Scene.

EHR

EHR Interoperability Leadership Health Data

Impetus and Edict: What the Latest CMS Data Standards Mean for EHRs – Regulatory Talk Series

Healthcare IT Today

DECEMBER 12, 2023

This article is the second in the Healthcare Regulatory Talk series. More regulatory churn is coming to shake up e-prescribing, this time with new data standards to step up clinical decision support at the point of care. For anyone counting, those are two major regulatory rules from CMS and ONC.

EHR

EHR Interoperability Medicare Health Information

Regulatory Compliance For Healthcare Organizations

Electronic Health Reporter

APRIL 8, 2020

There are several regulatory compliance requirements that healthcare organizations must follow. The article Regulatory Compliance For Healthcare Organizations appeared first on electronichealthreporter.com. By Jordan MacAvoy, vice president of marketing, Reciprocity Labs.

HIPAA

HIPAA Medicare

Amazon's One Medical acquisition passes regulatory hurdle in Oregon

Mobi Health News

JANUARY 4, 2023

The Oregon Health Agency said the deal is not likely to greatly reduce access to affordable care in the state, but it placed some conditions on its approval.

8 Information Blocking Regulatory Reminders

Healthcare IT Today

OCTOBER 1, 2022

Plus, Steve Posnack from ONC also published a blog article with eight regulatory reminders to help prepare people for October 6th. Reminder #4 – Not all health information that’s electronic is EHI under the regulatory definition. And if such information is not EHI, then it’s not covered by the information blocking regulations.

Health Information

Health Information Health IT Healthcare IT Leadership

Health IT Regulatory Roundup – Healthcare IT Today Podcast Episode 128

Healthcare IT Today

NOVEMBER 27, 2023

For the 128th episode of the Healthcare IT Podcast , we are doing a roundup focused on health IT regulatory news! Listen to Our Latest Episodes: For the 128th episode of the Healthcare IT Podcast, we are doing a roundup focused on health IT regulatory news! Thanks so much for listening!

Healthcare IT

Healthcare IT Health IT FHIR Telehealth

AI regulatory framework and workforce training key priorities says Cushnan

DigitalHealth

MARCH 14, 2023

A clearer regulatory framework and better health workforce training will help speed use of AI in the health system, the Rewired 2023 audience were told.

Digital Health

FDA looks to restrict older predicate devices, introduce new regulatory pathway

Mobi Health News

NOVEMBER 27, 2018

To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old.

healthcare technology

Integration of AI and E-Prescriptions Transform the European Online Pharmacy Landscape, While Regulatory Challenges Persist – ResearchAndMarkets.com

Digital Health Global

OCTOBER 25, 2023

However, challenges related to the regulatory environment and concerns about cyber threats and data security may pose obstacles to this burgeoning market. Challenge: Regulatory Environment The regulatory landscape for pharmacies varies from country to country in Europe, posing a challenge to the online pharmacy sector.

Digital Health

Woebot hires regulatory strategy exec and more digital health hires

Mobi Health News

AUGUST 23, 2022

Also: Decentralized clinical trial startup Curebase names vice president of clinical operations, and digital opioid use disorder-treatment company Ophelia hires a chief technology officer.

Digital Health

Study: Many digital health startups lack clinical trials, regulatory filings

Mobi Health News

JUNE 21, 2022

Of the 224 companies analyzed, 98 received a clinical robustness score of zero.

Digital Health

A quick regulatory guide to telehealth services in Japan

Healthcare IT News - Telehealth

JUNE 9, 2022

Telehealth services involve complex and evolving regulatory considerations and challenges in Japan. Although not intended to be a comprehensive guide, this article will highlight the regulatory issues that non-physician service providers need to be aware of as they seek to provide telehealth services in Japan.

Telehealth

Telehealth Telemedicine Pharmaceuticals Digital Health

Telehealth has staying power, should benefit from lasting regulatory changes

Healthcare IT News - Telehealth

MAY 6, 2020

Its requests include additional funding, regulatory flexibility for federal health programs and ensuring continued access to remote care. "Further, the continuation of many temporary policies, and enactment of new, permanent statutory and regulatory changes, will be needed as America returns to 'normal,'" she said.

Telehealth

Telehealth Telemedicine Medicare Healthcare IT

PainChek receives Singapore regulatory clearance and signs agreement with Allium Healthcare

Mobi Health News

AUGUST 5, 2019

Hot on the heels on being granted a US patent for pain assessment invention last month, Australia-based PainChek, developer of the world’s first smart phone-based pain assessment and monitoring app, has received regulatory approval from Singapore’s Health Sciences Authority (HSA) for the use of the PainChek app in the market.

Health science

New market guidances, regulatory pathway change proposals close out 2018 for FDA

Mobi Health News

DECEMBER 21, 2018

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

Digital Health

Building an interstate regulatory framework for telemedicine

Mobi Health News

SEPTEMBER 11, 2020

COVID-19 has made it clear that state-by-state licensure and other roadblocks to telehealth delivery should be left in the past, write Hims & Hers CEO Andrew Dudum and Health Innovation Alliance Executive Director Joel White.

Telemedicine

Telemedicine Telehealth

Regulatory challenges and involving clinicians in the health tech industry

Mobi Health News

MAY 13, 2019

Although health tech and digital health startups have much to offer in terms of transforming healthcare, they often face the challenges of overcoming regulatory hurdles, which are especially stringent in healthcare for the safety of patients.

Public Health

Public Health Digital Health

Fitbit’s ECG app gets regulatory clearance in U.S. and European Union

Mobi Health News

SEPTEMBER 14, 2020

The ECG app can detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm, according to study results.

CVS expects to close Oak Street Health deal by July as acquisition clears regulatory obstacle

FierceHealthIT

MARCH 31, 2023

CVS expects to close Oak Street Health deal by July as acquisition clears regulatory obstacle hlandi Fri, 03/31/2023 - 12:05

South Central Legislative/Regulatory Update – June 2020

South Central Telehealth Resource Center

JULY 14, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – June 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

South Central Legislative/Regulatory Update – May 2020

South Central Telehealth Resource Center

JUNE 10, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – May 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

House telehealth leaders move to cement regulatory changes for virtual care

FierceHealthIT

JULY 16, 2020

House telehealth leaders move to cement regulatory changes for virtual care. Thu, 07/16/2020 - 14:38.

Telehealth

Healthcare dealmaking 'resilient' despite regulatory, economic headwinds: PwC

FierceHealthIT

JUNE 21, 2023

Even in the face of substantial headwinds, dealmaking in the healthcare industry hasn't fallen off, according to a new analysis from PwC. Even in the face of substantial headwinds, dealmaking in the healthcare industry hasn't fallen off, according to a new analysis from PwC.

South Central Legislative/Regulatory Update – May 2020

South Central Telehealth Resource Center

JUNE 10, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – May 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

CMS provides regulatory relief on staffing, paperwork as COVID-19 cases surge

FierceHealthIT

MARCH 30, 2020

CMS put out a list of regulatory changes intended to help hospitals and health systems combat the surge of COVID-19 cases, including expanding capacity and boosting healthcare workforce.

Another regulatory investigation launched against Natural Cycles' contraceptive app

Mobi Health News

AUGUST 2, 2018

Natural Cycles, an app that bills itself as a contraceptive and fertility tracker, has again found itself the target of regulatory investigation due to claims made in its advertisements.

AppliedVR clears major regulatory hurdle to use virtual reality to treat chronic pain

FierceHealthIT

OCTOBER 21, 2020

AppliedVR clears major regulatory hurdle to use virtual reality to treat chronic pain. Wed, 10/21/2020 - 10:52.

South Central Legislative/Regulatory Update – March 2020

South Central Telehealth Resource Center

APRIL 9, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – March 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

South Central Legislative/Regulatory Update – February 2020

South Central Telehealth Resource Center

MARCH 4, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – February 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

Roundup: First insomnia DTx in South Korea gets regulatory nod and more briefs

Mobi Health News

FEBRUARY 16, 2023

Also, India has cleared the CardiacSense smartwatch for commercialisation.

FTC's backlog is delaying regulatory review of Beaumont-Spectrum merger, systems say

FierceHealthIT

SEPTEMBER 27, 2021

FTC's backlog is delaying regulatory review of Beaumont-Spectrum merger, systems say. Mon, 09/27/2021 - 12:15.

Mesh Bio bags $3.5M to bring digital twin tech to Hong Kong, Indonesia, Philippines

Mobi Health News

JANUARY 31, 2024

This comes three months after getting regulatory approval from Singapore’s Health Sciences Authority for its latest digital twin solution.

Health science

What Are The Current Regulatory Changes And Compliance Requirements That ASCs Need To Be Aware Of In Their Billing Practices?

Healthcare IT Today

JUNE 29, 2023

Understanding ASCs Regulatory Changes and Their Billing Practices Outpatient surgery centers (ASCs) perform many surgical procedures outside of hospitals. However, ASC billing practices must be followed to ensure proper reimbursement and regulatory compliance. Compliance is the foundation of ethical and responsible ASC billing.

Medicare

Medicare Medical Billing HIPAA Medical Billing Services

Actuaries project future virus surges, end of regulatory flexibility key drivers in 2022 rates

FierceHealthIT

SEPTEMBER 2, 2021

Actuaries project future virus surges, end of regulatory flexibility key drivers in 2022 rates. Thu, 09/02/2021 - 13:33.

South Central Legislative/Regulatory Update – January 2020

South Central Telehealth Resource Center

FEBRUARY 4, 2020

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – January 2020 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

South Central Legislative/Regulatory Update – May 2019

South Central Telehealth Resource Center

MAY 15, 2019

The following attachment is a list of legislative and regulatory updates compiled by the Center for Connected Health Policy (CCHP) for telehealth and telemedicine within the South Central region (Arkansas, Mississippi, and Tennessee). The post South Central Legislative/Regulatory Update – May 2019 appeared first on LearnTelehealth.

Health Policy

Health Policy Connected Health Telemedicine Telehealth

Major CMS Waivers and Regulatory Changes During COVID-19 Pandemic

Healthcare IT Today

MARCH 31, 2020

Yesterday, CMS announced an unprecedented level of Blanket Waivers and Regulatory changes to allow healthcare organizations to better deal with the COVID-19 pandemic. Many states had requested these waivers and been granted them, but now it applies to any state. AHIP has said that payers will follow suit in overwhelmed areas.

Healthcare IT

Healthcare IT Leadership Telemedicine Telehealth

After regulatory kerfuffle, EverlyWell finally rolls out home COVID-19 sample collection

Mobi Health News

MAY 19, 2020

The consumer-facing digital platform for health testing was forced to pump the brakes on a similar offering roughly two months ago.

MHRA publishes regulatory roadmap for development of medical devices

Prior authorization and other regulatory burdens have increased since last year, practices tell MGMA

Trending Sources

Balancing Innovation and Digital Transformation with Regulatory Compliance and Patient Safety

HeartBeam Appoints Deborah Castillo as Vice President of Regulatory Affairs

The State of Data and Insights in Healthcare Logistics

Healthcare IT Services and Their Role In 2021 Regulatory Compliance

Reimagining Health Tech on the Cusp of ONC’s Final HTI-1 Rule – Regulatory Talk Series

Impetus and Edict: What the Latest CMS Data Standards Mean for EHRs – Regulatory Talk Series

Regulatory Compliance For Healthcare Organizations

Amazon's One Medical acquisition passes regulatory hurdle in Oregon

8 Information Blocking Regulatory Reminders

Health IT Regulatory Roundup – Healthcare IT Today Podcast Episode 128

AI regulatory framework and workforce training key priorities says Cushnan

FDA looks to restrict older predicate devices, introduce new regulatory pathway

Integration of AI and E-Prescriptions Transform the European Online Pharmacy Landscape, While Regulatory Challenges Persist – ResearchAndMarkets.com

Woebot hires regulatory strategy exec and more digital health hires

Study: Many digital health startups lack clinical trials, regulatory filings

A quick regulatory guide to telehealth services in Japan

Telehealth has staying power, should benefit from lasting regulatory changes

PainChek receives Singapore regulatory clearance and signs agreement with Allium Healthcare

New market guidances, regulatory pathway change proposals close out 2018 for FDA

Building an interstate regulatory framework for telemedicine

Regulatory challenges and involving clinicians in the health tech industry

Fitbit’s ECG app gets regulatory clearance in U.S. and European Union

CVS expects to close Oak Street Health deal by July as acquisition clears regulatory obstacle

South Central Legislative/Regulatory Update – June 2020

South Central Legislative/Regulatory Update – May 2020

House telehealth leaders move to cement regulatory changes for virtual care

Healthcare dealmaking 'resilient' despite regulatory, economic headwinds: PwC

South Central Legislative/Regulatory Update – May 2020

CMS provides regulatory relief on staffing, paperwork as COVID-19 cases surge

Another regulatory investigation launched against Natural Cycles' contraceptive app

AppliedVR clears major regulatory hurdle to use virtual reality to treat chronic pain

South Central Legislative/Regulatory Update – March 2020

South Central Legislative/Regulatory Update – February 2020

Roundup: First insomnia DTx in South Korea gets regulatory nod and more briefs

FTC's backlog is delaying regulatory review of Beaumont-Spectrum merger, systems say

Mesh Bio bags $3.5M to bring digital twin tech to Hong Kong, Indonesia, Philippines

What Are The Current Regulatory Changes And Compliance Requirements That ASCs Need To Be Aware Of In Their Billing Practices?

Actuaries project future virus surges, end of regulatory flexibility key drivers in 2022 rates

South Central Legislative/Regulatory Update – January 2020

South Central Legislative/Regulatory Update – May 2019

Major CMS Waivers and Regulatory Changes During COVID-19 Pandemic

After regulatory kerfuffle, EverlyWell finally rolls out home COVID-19 sample collection

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