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-19 116

COVID-19 Governance Public Health FDA 116

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 This opinion piece reflects some of the content of a substantial article already accepted for publication by the University of San Diego Law Review. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Hall Render

JUNE 29, 2023

Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. Data Governance The Draft Guidance also strengthens the existing focus on data governance from both a sponsor and investigator perspective.

FDA 40

FDA Governance COVID-19 40

Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

FDA 40

FDA Governance Fraud Compliance 40

AIHC

JUNE 14, 2023

Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023. So, Who Regulates Healthcare AI?

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Healthcare Law Blog

FEBRUARY 1, 2022

In the attached article , we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.

Fraud 52

Fraud FDA Governance HIPAA 52

Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. Healthcare Laws.

FDA 90

FDA HIPAA Medicare Medicare 90

Healthcare IT Today

AUGUST 20, 2023

This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. That said, 66% trust their health plan more that the government or non-traditional entities such as Amazon or Walmart to their health insurance. Disease detection company Viz.ai

Health Insurance 97

Health Insurance Medicaid Medicaid FDA 97

MedTrainer

JUNE 4, 2024

In this article, I’ll discuss how pharmacies should focus compliance efforts on electronic prescribing, licensure, and CE. Pharmacy compliance is adhering to laws, regulations, and professional standards governing pharmacy practice. I’ll also share how compliance software helps streamline pharmacy document and policy management.

Compliance 52

Compliance Licensing Governance FDA 52

Bill of Health

FEBRUARY 27, 2024

Both Robert and Valentina Wasson published sensational magazine articles in Life! federal government remained unresponsive to the wealth of evidence supporting the therapeutic use of psychedelics. and This Week, respectively, along with subsequent texts that exposed María Sabina without consent, credit, or compensation.

Governance 120

Governance FDA World Health Health Outcomes 120

Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. According to a recent Science Magazine article , South Korea tested more than 270,000 people, which amounts to about 5200 tests per million! More than 250,000 cases of infection and over 10,000 deaths have been reported.

FDA 52

FDA Governance 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. This post is adapted from the author’s law review article on this topic , forthcoming in Volume 71, Issue 6 of the American University Law Review.

COVID-19 157

COVID-19 Public Health Governance COVID-19 Vaccine 157

Healthcare IT Today

OCTOBER 29, 2023

This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. Point-to-point encryption vendor Bluefin is integrating with CORE payment products for government and healthcare customers.

Medical Billing 108

Medical Billing FDA Hospitals Governance 108

Healthcare IT Today

JULY 25, 2022

The following is a guest article by Jack Wang , the V ice P resident of AOJ Medical. RPM devices work as medical devices which are governed by the FDA and related departments. That questionnaire can include things like how many engineers they have, the engineers background and education, etc.

FDA 97

FDA Licensing Governance Telemedicine 97

Compliance Now

AUGUST 1, 2022

Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above. The FAQs described in this article follow years of litigation and regulatory debate about the applicability of the contraception mandate to religious organizations.

FDA 100

FDA Medicare Medicare Governance 100

AIHC

JUNE 6, 2023

According to Investopedia’s article “ Understanding Machine Learning: Uses, Example ,” machine learning is the concept that a computer program can learn and adapt to new data without human intervention and is a field of artificial intelligence that keeps a computer’s built-in algorithms current regardless of changes in the worldwide economy.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

Healthcare IT Today

AUGUST 21, 2023

The following is a guest article by Peter Bloch, Market Development Manager – Healthcare at Avery Dennison Radio Frequency Identification (RFID) technology is revolutionizing healthcare, by improving efficiency, patient safety, and supply chain management. FDA’s Drug Supply Chain Security Act (DSCSA).

HIPAA 97

HIPAA Regulatory Compliance Hospitals FDA 97

AIHC

JUNE 6, 2023

According to Investopedia’s article “ Understanding Machine Learning: Uses, Example ,” machine learning is the concept that a computer program can learn and adapt to new data without human intervention and is a field of artificial intelligence that keeps a computer’s built-in algorithms current regardless of changes in the worldwide economy.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

MedTrainer

JULY 13, 2023

In this article, I’ll review how this technology is being used, the areas of greatest concern for compliance professionals, and ideas for maintaining compliance during this evolution. For example, when a human incorrectly codes an item, it happens one time.

Compliance 52

Compliance Compliance Officers FDA Governance 52

Healthcare IT Today

AUGUST 28, 2023

Regarding medication, several new psychiatric treatments have been approved by the FDA, including Auvelity for major depressive disorder, the SAINT transcranial magnetic stimulation protocol for treatment-resistant depression, and Zurzuvae for postpartum depression. The FDA’s RTA policy, effective Oct.

US Department of Health and Human Services 117

US Department of Health and Human Services Telemedicine Hospitals Compliance 117

Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. There is now an FDA policy released on 29 Feb. New cases are also being reported in the United States and several deaths have been confirmed.

US Department of Health and Human Services 52

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

Healthcare IT Today

JUNE 13, 2024

Despite challenges, the rigorous FDA approval process for AI used in clinical settings helps ensure safety and efficacy standards are met, mitigating concerns about patient safety and algorithmic reliability. Robust data governance and security measures should be adopted to protect patient data, including encryption and access controls.

Governance 75

Governance HIPAA Hospitals Informed Consent 75

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. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare IT Today

MAY 5, 2023

The following is a guest article by Erin Rutzler, Vice President of Fraud, Waste, and Abuse at Cotiviti In Delaware, more than 250 Medicare patients underwent unnecessary genetic testing based on telehealth consultations that often lasted less than two minutes— costing Medicare thousands of dollars per patient.

Fraud 62

Fraud Medicare Medicare Overpayments 62

Healthcare IT Today

DECEMBER 29, 2023

Sara Shanti, a partner specializing in health care technology at law firm Sheppard Mullin , says that the Executive Order and recent FDA guidance “start to provide real direction on how to navigate patient risk. ” This article looks at what’s special about AI in health care, and some ways to address its needs.

Department of Veterans Affairs 113

Department of Veterans Affairs FDA Doctors Licensing 113

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. Once signed into law, the effect of H.B. 152 , amending Utah Code § 26-60-103.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Healthcare IT Today

JUNE 27, 2023

The following is a guest article by Ryan Witt, Healthcare Cybersecurity Leader at Proofpoint The Internet of Medical Things, or IoMT, is a deep web of interconnected devices that increasingly plays a vital role in care delivery. Healthcare organizations, however, should not wait until these government mandates come into play.

Ransomware 105

Ransomware FDA Governance Hospitals 105

Healthcare IT Today

JANUARY 6, 2023

Earlier this year, a Harvard Business Review article cited a Kaiser Permanente study that showed members in California and the mid-Atlantic region with access to virtual primary care were 14 percent less likely to die from stroke and 43 percent less likely to die from heart disease.

US Department of Health and Human Services 116

US Department of Health and Human Services Doctors Telemedicine Public Health 116

HIPAA Journal

APRIL 5, 2023

Dissecting them all is beyond the scope of this article. To the Federal Drug Administration to report adverse events and track FDA-regulated products. When is Information being Released? To personal representatives of adult patients and unemancipated minor patients.

HIPAA 73

HIPAA Hospitals Compliance Medical Personnel 73

SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

FDA 40

FDA Licensing Governance Compliance 40

Healthcare IT Today

APRIL 23, 2023

This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. Believe it or not, that figure placed healthcare fifth among all industries, behind education, finance, insurance, and government.

Doctors 98

Doctors Hospitals FDA Governance 98

Healthcare It News

FEBRUARY 20, 2024

Challenges in diagnosing sleep apnea and research that shows positive airway pressure treatment can lower healthcare costs motivate healthcare organizations and government agencies like the U.S. New FDA update on Philips Respironics' 2021 device recalls PAP machines which deliver oxygen through a mask, are one way to treat sleep apnea.

FDA 277

FDA Governance 277

Healthcare IT Today

SEPTEMBER 12, 2023

The following is a guest article by Zach Markin, Co-Founder and CEO at HTD Health American healthcare is the most dysfunctional industry in our country. Historically, it is the most prolific driver of family bankruptcy, and now it is on its way to bankrupting our country collectively.

Nurses 66

Nurses Doctors Medicare Medicare 66

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. The addition of Annex 2, which describes the CPCA for N -nitrosamines.

FDA 40

FDA Compliance Licensing World Health 40

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

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. Cancer, as I argue in my forthcoming article, has become highly privatized. In 2017, 72% of U.S. Food and Drug Administration.

FDA 301

FDA Public Health Governance 301

SQA

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. 1, 2022 edition of the Newsletter includes a short article on the recent Advisory Committee on Safety of Medicinal Products (ACSoMP) meeting. . In addition, the No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40