Bill of Health

JUNE 26, 2023

have debated whether the government should produce drugs and biologics. Ultimately, the industry was successful in keeping the government away from biologics manufacturing by agreeing to abide by government regulations. Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it.

Pharmaceutical Industry 190

Pharmaceutical Industry Governance FDA Public Health 190

HIT Consultant

NOVEMBER 30, 2021

What You Should Know: Labcorp announced that it is offering an observed collection of COVID-19 PCR testing in over 500 patient service centers nationwide. To date, Labcorp has performed nearly 54 million COVID-19 PCR tests to detect the virus, provided instrumental data to government agencies like the CDC and the U.S.

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COVID-19 COVID-19 Vaccine FDA Doctors 59

Mobi Health News

JANUARY 2, 2019

Ongoing FDA submissions and other HHS services are safe, but new regulatory filings will have to be put on hold.

Governance 77

Governance FDA 77

Healthcare It News

NOVEMBER 16, 2023

Companies are expanding their reach with artificial intelligence through acquisitions, investments and government approvals on a near-daily basis. The company also said that it will continue to develop self-service tools for "prenatal care, advanced cancer screening and polygenic risk analysis." breast screening market.

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FDA Hospitals Doctors Governance 238

HIT Consultant

NOVEMBER 6, 2023

While the program won’t be implemented until the end of 2024 at the earliest and, as currently proposed, will cover only consumer-grade IoT devices, the government taking an active stance in establishing IoT security standards is significant. This is why such government initiatives are so welcome. vulnerabilities.

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Governance Ransomware FDA Hospitals 111

HIPAA Journal

JUNE 17, 2022

Food and Drug Administration (FDA) to review and update its guidelines on medical device cybersecurity more frequently to ensure devices are protected from potential hacking and cyberattacks. The bill, introduced by Sen.

FDA 97

FDA HIPAA Governance 97

Healthcare IT News - Telehealth

MAY 30, 2023

This change is yet another signal that the country is working to move past the pandemic, which falls in line with recent moves by the federal government to move the pandemic to a more controlled phase. Cozen O’Connor is a research and consulting firm with practices in litigation, business law and government relations.

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Telemedicine COVID-19 Governance Medicare 185

Healthcare IT Today

APRIL 28, 2023

But when it comes to putting the data in front of citizens, healthcare decision makers, government employees, and other key stakeholders, customer experience becomes a major part of the equation. Platform governance—an approach that establishes rules, practices, and standards—can create a hierarchy to manage cross organizational demands.

COVID-19 109

COVID-19 Governance Public Health FDA 109

Healthcare IT News - Telehealth

JANUARY 19, 2021

"We've been measuring the risks and the threat for telemedicine-type services for many years," said Christopher Logan, director of healthcare industry strategy at VMWare. Jarrett noted that this could be a good opportunity for the government to intervene. "Cybersecurity is a patient safety issue.

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Telemedicine Ransomware FDA COVID-19 217

HIT Consultant

MARCH 19, 2023

The US government spent an estimated $350 million on advertising around the COVID-19 pandemic and COVID vaccine public health campaigns with the combined expenses from the Department of Health and Human Services and the Department of Education totaling $520 million. billion marketing the medication. billion marketing the medication.

US Department of Health and Human Services 98

US Department of Health and Human Services Hospitals COVID-19 FDA 98

Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S Companies ( Contract Research Organizations ) offering their services to assist Sponsors are already promoting their use of “AI” to obtain “more diverse” populations. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Healthcare Law Blog

MAY 31, 2022

Developers and other players in the metaverse offering health-related products and services will face an ever-growing patchwork of state and federal privacy and data security laws. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area. Healthcare Laws.

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FDA HIPAA Medicare Medicare 90

Dot Compliance

JUNE 16, 2022

Government regulators have been doing their best to ensure that patients receive the safest and most efficient device possible. The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. What are the main regulations governing medical device QMS?

FDA 52

FDA Regulatory Compliance Compliance Governance 52

MedTrainer

JANUARY 12, 2024

Healthcare compliance is the process of following the laws, regulations, and ethical standards that govern the healthcare industry. Here are some of the key organizations involved in regulating healthcare compliance: Centers for Medicare & Medicaid Services (CMS): CMS is a federal agency within the U.S.

Compliance 52

Compliance Fraud Medicaid Medicaid 52

Healthcare Law Today

FEBRUARY 1, 2022

Provides grants to eligible entities for research and demonstration projects that support the improvement of emergency medical services and trauma care in rural areas. The pilot program, which will wind down at the end of 2027, first requires the FDA to issue guidance on implementation and to provide regular reporting on projects.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 98

Compliance Now

AUGUST 1, 2022

On July 28, 2022, the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) issued new FAQs clarifying their interpretation of the ACA’s requirement that non-grandfathered health plans provide contraception to participants at no cost. By: Jennifer Berman, CEO, MZQ Consulting. Medical Management.

FDA 100

FDA Medicare Medicare Governance 100

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

She is a member of the clinical leadership at Done, a platform that connects patients with psychiatric board-certified medical professionals for services including online video consultations , diagnosis, care team support and prescription delivery. Zoe Martinez has three predictions. What does this mean for mental healthcare this year?

COVID-19 146

COVID-19 Public Health Licensing FDA 146

Healthcare IT Today

JULY 25, 2022

RPM service and Telehealth are not new topics In the current health care market, and many RPM and Telehealth vendors have already set up services, systems, and applications for specified diseases or target patients. RPM devices work as medical devices which are governed by the FDA and related departments.

FDA 88

FDA Licensing Governance Telemedicine 88

HIT Consultant

JANUARY 24, 2022

Are we putting enough safeguards and governance in place for AI-driven decision-making, particularly in areas of automated machine learning? That’s why the theme of a recent FDA-Project Data Sphere Symposium was entitled “The Art of the Possible.” Are humans in the process loop to verify both inputs and outputs of AI predictions?

Governance 98

Governance FDA Doctors COVID-19 98

Healthcare IT Today

AUGUST 28, 2023

Stephen Sofoul, SVP, Data & Decision Science Services at MultiPlan A critical challenge lies in the shortage of experienced financial analysts or data analysts capable of effectively analyzing the wealth of information that the healthcare industry holds. The following is what they had to say.

US Department of Health and Human Services 111

US Department of Health and Human Services Telemedicine Hospitals Compliance 111

HIT Consultant

DECEMBER 14, 2021

They are focused on expanding the number of providers who can prescribe the treatment (it requires a special waiver from the federal government) and training more clinicians to provide support needed for the treatment to be successful. government agencies to develop OUD treatment protocols for decades.

Licensing 98

Licensing Governance FDA Telemedicine 98

American Medical Compliance

MAY 13, 2024

The Opioid Epidemic As of October 16, 2017, the US government officially declared the opioid epidemic a public health emergency. Different governmental agencies have distinct roles in regulating opioids, providing healthcare services, and enforcing laws. To become certified, please visit us at American Medical Compliance (AMC).

Compliance 52

Compliance Public Health Governance FDA 52

Health Populi

OCTOBER 8, 2021

Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA. FDA clearance makes a difference in peoples’ trust with health apps, with 2 in 3 U.S. consumers likely to use an FDA-approved health tracking tool. 46% of U.S. Mood nearly doubling in interest to 24%.

COVID-19 77

COVID-19 FDA Public Health Governance 77

AIHC

JUNE 14, 2023

The Health & Human Services (HHS) response to OMB Memorandum 21-06 “ Guidance for Regulation of Artificial Intelligence Applications ” was drafted in November 2020 and is directed to the heads of all Executive Branch departments and agencies, including independent regulatory agencies.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

HIPAA Journal

NOVEMBER 4, 2022

Warner suggests the only way to improve healthcare cybersecurity rapidly is through a collaborative effort involving the public and private sectors, with the federal government providing overall leadership. Improve Federal Leadership. Reduce the Cost of Cyber Insurance.

HIPAA 114

HIPAA Governance FDA Medicaid 114

Bill of Health

MAY 30, 2023

Food and Drug Administration (FDA) approval in 2000, mifepristone generally has remained available under specific conditions of use defined under its Risk Evaluation and Mitigation Strategy (REMS) Program. For example, in December 2021, the FDA permanently lifted its general in-person dispensing requirements for mifepristone.

Telemedicine 28

Telemedicine FDA Governance Public Health 28

Verisys

DECEMBER 1, 2022

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. Verisys is fully certified by both NCQA for 11 out of 11 certification services and URAC accredited. FACIS Level 3 background screening of federal sources. SAM ( including SDN ). State Dept.

Medicaid 52

Medicaid Medicaid Fraud Governance 52

Redox

OCTOBER 12, 2023

By 2025, the compound annual growth rate of healthcare data will reach 36%—6% faster than manufacturing, 10% faster than financial services, and 11% faster than media and entertainment. The FDA has approved more than 500 AI and machine learning models for medical use—most of which are in radiology.

FDA 69

FDA Hospitals Medicare Medicare 69

Healthcare IT Today

AUGUST 20, 2023

That said, 66% trust their health plan more that the government or non-traditional entities such as Amazon or Walmart to their health insurance. MedArrive and Heartbeat Health are collaborating to provide on-demand cardiovascular services to Medicaid beneficiaries. Disease detection company Viz.ai

Health Insurance 91

Health Insurance Medicaid Medicaid FDA 91

Healthcare Law Today

JANUARY 20, 2022

However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to such tests, including the Clinical Laboratory Improvement Amendments (CLIA), which govern most laboratory testing and the operations of clinical laboratories.

COVID-19 52

COVID-19 FDA Licensing Medicaid 52

Bill of Health

OCTOBER 27, 2022

Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines. In 2021, the Supreme Court articulated in Tandon v. Throughout that period, federal courts have respected those decisions.

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COVID-19 Public Health Governance COVID-19 Vaccine 157

Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Verisys designed and built the first data-powered Software as a Service (SaaS) credentialing platform, CheckMedic, 20 years ago.

Licensing 52

Licensing Medicaid Medicaid Governance 52

AIHC

JUNE 6, 2023

Medical coding and billing is a complex process that involves translating healthcare services, diagnoses, and procedures into standardized codes. Beware of new companies offering such services. We can all be hopeful that use of AI will improve disease diagnosis and monitoring, clinical workflow augmentation, and hospital optimization.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

SQA

JUNE 10, 2021

A total of 53 normative acts and two Guides were issued regarding the access to essential products and services in the fight against the new coronavirus. There are 11 regulatory projects for the medical devices’ field: Implementation of the National Implant Registry (RNI) in Brazil’s public and private health services.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare IT News - Telehealth

DECEMBER 1, 2021

We also know that utilization has gradually tapered off as patients have become somewhat more comfortable seeking in-person care – but that many individuals, having experienced the convenience of virtual services, are unwilling to give them up again. You've mentioned reimbursement and paying for remote patient monitoring.

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COVID-19 Public Health Doctors Governance 167

Bill of Health

FEBRUARY 9, 2024

Currently, TST offers the services only to patients in New Mexico, but it plans to expand into other states. FDA , which examines whether clinicians can provide medication abortion through telehealth or whether this requires an in person appointment. In January 2023, FDA removed the in-person dispensing requirement.

FDA 40

FDA Governance 40

HIT Consultant

JANUARY 9, 2023

This is a period of major transition for the industry, with some health plans struggling to maintain their previous ratings and plan participants, who are now accustomed to home-based testing and treatment, expecting those services and features to continue. It also impacts government payment rates. About Paula LeClair.

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Medicare Medicare FDA COVID-19 52