Healthcare IT Today

JANUARY 21, 2025

Just last year, the FDA released new guidance on cybersecurity for medical devices, including requirements for securing medical devices postmarket. The FDAs primary guidance is that manufacturers have a plan for the rapid testing, evaluation, and patching of devices deployed in the field. Whats Next? He leads a team of former U.S.

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FDA Governance Hospitals 109

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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Governance Public Health HIPAA COVID-19 130

HIPAA Journal

MARCH 30, 2023

Food and Drug Administration (FDA) will not authorize their use. trillion omnibus spending bill – The Consolidated Appropriations Act, 2023 – took effect and the FDA now requires all regulatory submissions for medical devices to include information about the cybersecurity measures that have been implemented for the devices.

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FDA HIPAA Governance Compliance 116

HIPAA Journal

OCTOBER 1, 2022

The FDA’s authorization to collect fees from the healthcare sector to conduct independent reviews of drugs and medical devices was due to come to an end on September 30, and with time running out, the FDA bowed to pressure from Senate republicans and stripped out the new cybersecurity requirements for medical device manufacturers.

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FDA HIPAA Governance 106

Hall Render

APRIL 28, 2025

Background For decades, LDTsin-house diagnostic tests developed, validated, and performed within a single laboratoryhave been regulated by states and the Centers for Medicare & Medicaid Services (“CMS”) under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), while FDA exercised enforcement discretion.

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Fierce Healthcare

JULY 8, 2024

Two high-ranking government officials have abdicated their roles on the board of the Coalition for Health AI, the organization and HHS confirmed.

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FDA Governance 122

Fierce Healthcare

MARCH 4, 2025

The Department of Government Efficiency has cancelled leases of federal buildings at the FDA and other agencies, as the feds look for alternative ways to divest office buildings.

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FDA Governance 126

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 Today

MAY 5, 2025

Food and Drug Administration (FDA) and has a longstanding influence with regulatory agencies in Europe and Asia-Pacific (APAC). ATA Action has successfully advocated for a sea change of positive telehealth legislation at the federal and state levels of government. DTA has a positive, established relationship with the U.S.

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Telemedicine FDA Federal Policy Governance 67

Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A New Way to Contain Unaffordable Medication Costs – Exercising the Government’s Existing Rights. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. PMID: 35201276.

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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.

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Pharmaceutical Industry Governance FDA Public Health 195

Healthcare It News

DECEMBER 1, 2021

As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. Whether it's government payers or the commercial payers, they have started to cover more and more of these initiatives. You've mentioned reimbursement and paying for remote patient monitoring.

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Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

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COVID-19 FDA Health Insurance Doctors 257

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.

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Governance FDA 83

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. " FDA clears Lunit breast cancer screening algorithm Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, announced Tuesday that the U.S.

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Healthcare IT Today

DECEMBER 22, 2024

Partnerships Identity security vendor SailPoint acquired Imprivatas identity governance and administration business , and the two companies will become go-to-market partners. It’s initially being used in Stelo, Dexcom’s FDA-cleared over-the-counter glucose biosensor.

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Medicare Medicare FDA Telemedicine 84

Bill of Health

MARCH 13, 2025

This is complemented by the European Medicines Agency (EMA)s Policies 70 and 43 , which further govern access to clinical data for approved medicines. FDA and Food Marketing Institute v. By contrast, the U.S. By contrast, the U.S. Recent court decisions, including Seife v.

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Public Health FDA Governance Compliance 130

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

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COVID-19 FDA Health Insurance Doctors 246

Mobi Health News

OCTOBER 1, 2018

Scott Gottlieb detailed his agency’s ongoing cybersecurity efforts, which include the signing of two “significant memoranda of understanding” and discussions to facilitate collaboration across government agencies.

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FDA Governance 93

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

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FDA COVID-19 Governance Medicaid 116

Bill of Health

MARCH 4, 2024

Stigler argued that the government’s main “resource” is the “power to coerce,” and therefore a rational interest group would seek to convince the government to use its coercive power for the group’s own benefit. But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy.

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FDA Governance 140

HIT Consultant

MAY 5, 2025

This plan is then delivered and monitored through Laina, an FDA-registered, HIPAA-compliant WebAI assistant. .” The LainaHealth Model: Combining Human Expertise with AI The LainaHealth model begins with a DPT evaluation and a personalized care plan.

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Patient Satisfaction FDA Licensing Doctors 52

Healthcare IT News - Telehealth

JANUARY 22, 2021

For reimbursement by the CMS, a device must be an FDA-listed device. However, an FDA approval ensures a medical device is safe and effective for its intended use. FDA classifies medical devices into three classes based on risk to human life. Dr. Joyoti Goswami is a Principal Consultant at Damo Consulting.

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US Department of Health and Human Services COVID-19 FDA Governance 190

Bill of Health

JANUARY 26, 2024

Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.” When we discuss FDA clinical trials , we’re talking big money , so clarity matters here. cocaine ?).

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FDA Governance Health Insurance 193

Bill of Health

DECEMBER 6, 2024

The EU AI Act , proposed EU AI Liability Directive , and laws under the European Strategy for Data , such as the Data Governance Act , may also play roles. US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework.

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FDA Governance Compliance Bioethics 130

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. government. government substantially de-risking the vaccine development process.

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COVID-19 Vaccine COVID-19 Governance Public Health 147

Dot Compliance

MAY 2, 2025

Regulations like FDA 21 CFR Part 11, EU Annex 11, ISO 13485 , and ICH Q10 all mandate strict control over quality processes, documentation, and electronic records. AI governance within an eQMS must balance innovation with risk management. Manual or fragmented systems make it difficult to meet these standards.

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Compliance FDA Regulatory Compliance Governance 59

Healthcare IT Today

MARCH 26, 2025

Federal and state agencies, including the Drug Enforcement Administration ( DEA ) and the Food and Drug Administration (FDA), are shaping the future of telehealth through evolving policies. The FDA also plays a key role in overseeing online pharmacies to ensure they comply with federal drug distribution laws.

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Healthcare Law Blog

AUGUST 3, 2022

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”.

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Governance FDA Medicare Medicare 52

Healthcare IT Today

JANUARY 3, 2025

By 2025, these systems will likely integrate compliance features seamlessly, automatically tracking drug expiration dates, managing recalls, and ensuring adherence to evolving government regulations. There will be no in-between. That would send shockwaves through the whole pharma industry.

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Pharmaceutical Industry FDA Compliance Regulatory Compliance 88

HIPAA Journal

MARCH 15, 2023

Technologies include FDA-regulated devices, non-FDA-regulated devices, laboratory equipment, building and facilities technology, and a host of other technologies. Many different technologies are used that similarly become more vulnerable as they age, and continue to be used after end-of-life has been reached and support is withdrawn.

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FDA Governance Public Health HIPAA 109

Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ). In its February 2022 report, the U.S.

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FDA COVID-19 Compliance Governance 52

Verisys

APRIL 8, 2025

FACIS Level 1M Background Check A FACIS Level 1M background check is the recommended baseline and minimally required compliance search for candidates employed by organizations that receive any government funding for state or federal health care programs. Treasury Dept U.S. State Dept Which Level of FACIS Search Does Your Organization Need?

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Fraud Medicaid Medicaid Compliance 52

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. A bipartisan bill – The Strengthening Cybersecurity for Medical Devices Act – has been introduced which calls for the U.S.

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FDA HIPAA Governance 106

Bill of Health

SEPTEMBER 21, 2024

Food and Drug Administration (FDA), and Department of Health Human Services (HHS). It may very well be that deciding when an alpha amino acid polymer is a “protein” to be regulated by the FDA is not simply a question of statutory interpretation, but also a question of science and policy. Loper Bright overturned Chevron v.

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FDA ACA Governance 124

Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority.

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FDA Compliance Governance Public Health 98

Bill of Health

DECEMBER 26, 2023

Here, the DoJ found that Massachusetts General Hospital discriminated under the ADA by denying a patient, Bryan, the opportunity to be listed on the lung transplant waiting list because he was taking Suboxone, an FDA-approved treatment for opioid use disorder. Bryan ultimately obtained a transplant at the University of Pennsylvania.

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