Bill of Health

NOVEMBER 18, 2022

In fact, before publishing the book, the authors petitioned the government, highlighting glaring regulatory issues, but the government turned a blind eye. The book relies on primary sources of information — mainly government reports, judicial decisions, and government data.

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Governance Bioethics FDA Public Health 321

Health Populi

JULY 28, 2020

This week, announcements from the Consumer Technology Association (CTA) and Withings further bolster the case for the private sector bolstering public health in this pandemic…and future ones to come beyond the Age of the Coronavirus. On 27th July, CTA announced the Association’s launch of the Public Health Tech Initiative.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

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 195

Pharmaceutical Industry Governance FDA Public Health 195

Bill of Health

APRIL 7, 2023

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. public investment in the development of mRNA COVID-19 vaccines between 1985 to 2019.

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COVID-19 Vaccine COVID-19 Governance Public Health 147

Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. The sectorialism of the U.S.

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FDA Malpractice Regulatory Compliance Health Insurance 288

HIPAA Journal

DECEMBER 22, 2022

trillion omnibus appropriations bill has been released by the House and Senate Appropriations Committees which, if passed, will ensure that the government remains funded until September 30, 2023. The bill must be signed by the president on Friday this week, when government funding is set to expire. The text of a $1.7

FDA 117

FDA COVID-19 Governance Medicaid 117

Healthcare IT News - Telehealth

MAY 30, 2023

The COVID-19 public health emergency came to an end on May 11. 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.

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Telemedicine COVID-19 Governance Medicare 216

Bill of Health

OCTOBER 30, 2024

The data show children are especially vulnerable during the development of the prefrontal cortex in the brain, which governs higher reasoning, goal setting, and impulse control. Holding TikTok liable for addicting a generation to their app begins the process of remedying the mental health crisis in children.

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Healthcare IT Today

APRIL 28, 2023

The following is a guest article by Chris Anello, Director of Digital Platforms at iTech AG The COVID-19 pandemic pushed healthcare organizations to the edge and exposed both challenges and opportunities related to public health data. For healthcare modernization initiatives to succeed, CX must remain top of mind.

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COVID-19 Governance Public Health FDA 128

HIPAA Journal

MARCH 15, 2023

This month, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published guidance to help healthcare delivery organizations effectively manage cyber risks associated with legacy technology.

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FDA Governance Public Health HIPAA 110

The Digital Health Corner

NOVEMBER 28, 2016

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

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Public Health Health Services Administration Patient Advocacy Governance 68

Dot Compliance

FEBRUARY 22, 2022

If you’ve developed a new pharmaceutical and want to market it to health care providers or the general public, you must take one first, unskippable step: you need to get it approved by the Food and Drug Administration. FDA regulations govern what you can claim about your product and whether you can even sell it at all.

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FDA Compliance Governance Public Health 98

HIT Consultant

MARCH 19, 2023

However, few health systems, medical practices, or providers are prepared for the extraordinary public interest in a treatment for Alzheimer’s disease – especially not one targeting mild cognitive impairment (MCI) and early dementia due to Alzheimer’s disease – that is likely headed their way soon. billion marketing the medication.

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

Healthcare Law Today

FEBRUARY 1, 2022

It also requires that the Secretary report to Congress on the state of the SNS, and to issue guidance and hold annual meetings with public health officials and stakeholders on how states, territories, and Tribes can access the SNS. Modernizes public health data through biosurveillance and infectious disease data collection.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 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 There is also precedent for the public health and research community to act on its own. While the U.S.

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Informed Consent FDA Public Health World Health 130

HIPAA Journal

DECEMBER 8, 2022

The AHA said “hospitals and health systems have prioritized protecting patients and defending their networks from cyberattacks. However, they need support from the federal government as the field continues to face targets from sophisticated cyber adversaries and nation-states.”.

HIPAA 131

HIPAA FDA Governance Hospitals 131

Health Populi

JANUARY 29, 2019

More philanthropic organizations targeting neglected tropical and public health diseases. IQVIA rightly calls out digital therapeutics (DTx) in this year’s report, noting the growth of mobile apps and digital tools submitted to the FDA for clearance or approvals. Thus far, the FDA has been welcoming to these concepts.

Prescription Drug Pricing 101

Prescription Drug Pricing FDA Patient Advocacy Governance 101

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

Despite the end of the public health emergency, individuals and informed political leaders will continue to work with pharmacies to continue access to vital care for individuals in need of medication for mental health because mental health is part of overall health.

COVID-19 184

COVID-19 Public Health Licensing Telemedicine 184

HIT Consultant

APRIL 1, 2024

Among its efforts is a focus on promoting community-level health behaviors, such as increasing screening efforts; reinforcing the benefit of prescription and over-the-counter medications; and targeting communities that are at elevated risk for heart disease due to social and economic conditions. But now is the time to reverse those setbacks.

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COVID-19 Governance Public Health FDA 98

Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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FDA Governance Medicare Medicare 59

Health Populi

OCTOBER 8, 2021

More Boomers are concerned with health data app privacy than Gen Z consumers, as the chart illustrates. adults said that health monitoring apps were not an invasion of privacy; 32% said they were, Morning Consult found. Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA.

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COVID-19 FDA Public Health Governance 83

Healthcare IT News - Telehealth

DECEMBER 16, 2020

“Regulators, for their part, have tried to smooth the way for a pivot to virtual during the public health emergency. ” The FDA is hinting that some of these changes could be here to stay. " “Some private insurers stepped in to help, too,” they added.

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COVID-19 Hospitals Doctors Health Insurance 218

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. CARPL is also creating an impact in the public health space by working with the Government of India to enable large-scale Tuberculosis Screening Programmes in the most remote regions of the country.

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FDA Governance Hospitals Health Outcomes 120

Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. Do these encounters comport with telehealth encounter requirements set forth by applicable state laws, or government or private payor requirements? How is this disclosed to consumers?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Healthcare IT Today

FEBRUARY 18, 2024

eHealth Exchange is launching an incentive program that will waive annual fees for three years to the first five HIEs or state/local public health agencies that agree to exchange public health data. Additionally, 89% of patients said the ability to manage their health in a single platform is as least somewhat important.

Hospitals 95

Hospitals Public Health FDA Governance 95

Health Populi

FEBRUARY 4, 2019

Consumers point to some organizations that they perceive may be working against their better health: these include fast food manufacturers, the entertainment industry, food processors (“Big Food”), the media, government agencies, and health insurance companies. Health care delivery in the U.S.

Doctors 124

Doctors Nurses Public Health Medical Billing 124

Bill of Health

JUNE 1, 2022

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic. These decisions are devastating, and likely signal a continued attack on government authority , but they are not a reason to give up.

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COVID-19 Governance FDA COVID-19 Vaccine 299

Bill of Health

FEBRUARY 27, 2024

federal government remained unresponsive to the wealth of evidence supporting the therapeutic use of psychedelics. With this, we’ve seen the emergence of a few dominant players engaged in what might be described as rent-seeking behavior , or seeking to monopolize aspects of the market for financial gain. For decades, the U.S.

Governance 124

Governance FDA World Health Health Outcomes 124

Health Populi

AUGUST 3, 2018

A new poll jointly conducted by Politico and the Harvard Chan School of Public Health bolsters my read on the latter issue – prescription drug pricing, which has become a mass popular culture union. There may be no other issue on voters’ collective minds for the 2018 mid-term election that so unites American voters.

Prescription Drug Pricing 67

Prescription Drug Pricing FDA Public Health Medicare 67

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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

HIT Consultant

JANUARY 31, 2024

These instructions should adhere to relevant FDA guidance and should involve the use of common healthcare cleaning products. Insufficient Governance of AI Used in Medical Technologies Risks Inappropriate Care Decisions AI offers the promise of speeding up processes and assisting in clinical decisions.

Medical Device Industry 98

Medical Device Industry Ransomware FDA Public Health 98

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. As a physician who is invested in complying with current regulations, I welcome clear regulatory guidelines from both the FDA and the DEA on these matters.

US Department of Health and Human Services 128

US Department of Health and Human Services Telemedicine Hospitals Compliance 128

Healthcare IT Today

JANUARY 6, 2023

An end to the Public Health Emergency (PHE) is likely to be announced and end mid-January followed by a grace period of approximately 5 months. And with the Public Health Emergency (PHE) set to expire in January, stakeholders are urgently calling upon Congress to pass the Advancing Telehealth Beyond COVID-19 Act of 2021.

US Department of Health and Human Services 102

US Department of Health and Human Services Doctors Telemedicine Public Health 102

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. For dental healthcare providers, this public health emergency signifies a critical need to be vigilant and proactive in opioid prescribing practices.

Public Health 52

Public Health Compliance Governance FDA 52

HIT Consultant

APRIL 4, 2023

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

FDA 52

FDA Medicaid Medicaid COVID-19 52

Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. Building a nutrition label for health equity – learning from MITRE . Questions about the ethics and governance of AI in health are being posed globally.

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FDA Governance Fraud World Health 71

AIHC

JUNE 14, 2023

The question remains, how will the use of AI be regulated for health care use? The Federal Drug Administration & AI The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML.

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FDA HIPAA Compliance Regulatory Compliance 45