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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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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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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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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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.

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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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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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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?

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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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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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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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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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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.

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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.

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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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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.”.

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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.

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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.

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Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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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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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.

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HIPAA Journal

MARCH 20, 2023

Senate Committee on Homeland Security and Governmental Affairs held a hearing to examine cybersecurity risks to the healthcare sector, how healthcare providers and the federal government are working to combat those threats, and determine what the federal government needs to do to improve defenses against cyberattacks on the healthcare sector.

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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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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.

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Bill of Health

NOVEMBER 15, 2023

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of U.S.

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Healthcare IT News - Telehealth

JULY 16, 2020

Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. The preliminary injunction is only in effect during the public health emergency, but ACOG's Perryman said the organization has been pushing to end the regulations more broadly.

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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.

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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.

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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.

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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.

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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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Healthcare IT News - Telehealth

JANUARY 3, 2022

"Mail is regulated by the federal government," said lawyer David Coale to ABC affiliate KVUE. Although the vast majority (with a few exceptions) had moved to expand telehealth access, most had also pursued change via administrative action – meaning the solutions may not be permanent after the public health emergency.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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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.

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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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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.

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Bill of Health

SEPTEMBER 28, 2023

Pressure from Senator Bernie Sanders, Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee seems to have catalyzed the administration to make this move. It is unlikely that the removal of a reasonable pricing condition on products funded by the federal government contributed to an increase in CRADAs.

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