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.

FDA 101

FDA Governance Public Health HIPAA 101

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.

COVID-19 124

COVID-19 Governance Public Health FDA 124

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. The former actually further a state’s interest in promoting public health, unlike religious exemptions, which subvert this goal.

COVID-19 162

COVID-19 Public Health Governance COVID-19 Vaccine 162

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.

FDA 59

FDA Governance Medicare Medicare 59

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.

US Department of Health and Human Services 98

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

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.

Public Health 68

Public Health Health Services Administration Patient Advocacy Governance 68

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.

Governance 321

Governance Bioethics FDA Public Health 321

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

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.

FDA 98

FDA Compliance Governance Public Health 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.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

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.

Telemedicine 190

Telemedicine COVID-19 Governance Medicare 190

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.

COVID-19 299

COVID-19 Governance FDA COVID-19 Vaccine 299

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

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.

COVID-19 98

COVID-19 Governance Public Health FDA 98

Healthcare IT News - Telehealth

DECEMBER 1, 2021

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. What is driving all this, of course, is the regulatory changes during this public health emergency. First of all, we should think about the public health emergency.

COVID-19 169

COVID-19 Public Health Doctors Governance 169

Healthcare IT Today

NOVEMBER 6, 2024

Food and Drug Administration (FDA) to explore its use for reporting adverse effects in clinical trials. With this knowledge, we successfully leveraged the viability of Networked FHIR for prior authorization with UC Davis Health, Regence, and other eHealth Exchange participants.

HIPAA 80

HIPAA Public Health FDA Health Insurance 80

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.

FDA 100

FDA Health Outcomes Public Health Governance 100

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.

COVID-19 83

COVID-19 FDA Public Health Governance 83

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 117

HIPAA FDA Governance Hospitals 117

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 120

Hospitals Public Health FDA Governance 120

Bill of Health

AUGUST 4, 2024

Haupt In addition to the conflict between free speech and public health in connection with social media , the role of social media as a public health hazard in itself has gained attention. He based this proposal on a range of alleged public health harms caused by social media, especially among young users.

Public Health 165

Public Health FDA Governance 165

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.

Compliance 52

Compliance Public Health Governance FDA 52

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.

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

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-19 148

COVID-19 Public Health Licensing Telemedicine 148

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

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

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

Bill of Health

OCTOBER 31, 2024

by Alice Bryk Silveira The alarming rise in diabetes and obesity rates in the United States has placed significant strain on health care systems and poses a serious public health threat. Despite international momentum and calls from public health experts, the United States remains behind. Since 2009, the U.S.

Public Health 100

Public Health FDA Governance Licensing 100

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.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

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 124

US Department of Health and Human Services Telemedicine Hospitals Compliance 124

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

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 132

US Department of Health and Human Services Doctors Telemedicine Public Health 132

Bill of Health

OCTOBER 5, 2023

By Hannah Rahim Algorithms used in health care have the potential to improve health outcomes but are susceptible to racial bias , which can have detrimental consequences for minority populations. Food and Drug Administration (FDA) has also begun to consider the regulation of clinical algorithms.

FDA 162

FDA Governance Public Health Hospitals 162

Bill of Health

NOVEMBER 13, 2023

In fact, the majority of Americans do not hold strong trust in our health agencies like FDA and CDC. In my forthcoming article, I argue that our cancer regulatory regimes inadequately protect the public. The Privatization of Cancer Privatization is the transfer of public power to private hands. In 2017, 72% of U.S.

FDA 306

FDA Public Health Governance 306

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.

COVID-19 213

COVID-19 Hospitals Doctors Health Insurance 213