HIPAA Journal

APRIL 11, 2022

Food and Drug Administration (FDA) has issued new draft guidance for medical device manufacturers to help them incorporate cybersecurity protections into their products at the premarket stage, and to ensure security risks are managed for the full life cycle of the products. The FDA will then work on a final version of the guidance.

FDA 136

FDA HIPAA 136

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA.

FDA 113

FDA HIPAA Compliance 113

Healthcare Dive

JANUARY 7, 2025

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.

FDA 184

FDA 184

Bill of Health

SEPTEMBER 23, 2022

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. Patients seeking to use a product via EA must have a serious or life-threatening condition for which there are no comparable FDA-approved treatments or clinical trial options available.

FDA 237

FDA Informed Consent Public Health 237

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.

FDA 115

FDA HIPAA Governance Compliance 115

HIT Consultant

OCTOBER 22, 2024

OneStep’s AI-Powered Platform Key Features OneStep’s FDA-listed, AI-powered platform offers continuous, real-life monitoring of patient gait and mobility. Streamline Documentation: Automate documentation processes and reduce administrative burden.

FDA 98

FDA 98

Bill of Health

MARCH 12, 2024

Yet, once approved, FDA will put limits on the approved drug. The MDMA NDA Back in December 2023, Lykos Therapeutics (formerly MAPS PBC ) submitted a New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which FDA recently granted priority review.

FDA 214

FDA Doctors Hospitals 214

Mobi Health News

FEBRUARY 6, 2019

Released yesterday, the document outlines FDA's preference toward single applications for combination products.

FDA 108

FDA 108

Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.

FDA 98

FDA Public Health COVID-19 Compliance 98

HIT Consultant

MAY 9, 2022

From documenting clinical care to filing medical claims and registering patients, paper documents have been entrenched in healthcare processes since the inception of modern hospitals. Going digital in healthcare requires the adoption of electronic documents. Healthcare stakeholders have long relied on paper-based processes.

FDA 98

FDA COVID-19 Public Health Compliance 98

Healthcare IT Today

NOVEMBER 22, 2024

OneStep’s FDA-listed, AI-powered care platform offers continuous, real-life monitoring, empowering healthcare providers with actionable, real-time data. Providers can enhance patient outcomes, improve decision-making, streamline documentation, and reduce costs while also generating new revenue through Remote Therapeutic Monitoring (RTM).

FDA 97

FDA Nurses 97

HIT Consultant

JANUARY 22, 2024

Food and Drug Administration (FDA) 510(k) clearance for its latest update, v3.0.0. – This FDA clearance paves the way for American hospitals to now harness the software’s advanced capabilities, marking a significant step forward in lung disease diagnosis and treatment. .

FDA 96

FDA Hospitals 96

HIT Consultant

DECEMBER 3, 2024

Many care settings are required to perform elaborate intake and documentation before even beginning treatment for a patient. The FDA is approving digital therapeutics tools (i.e., Much like your doctor writes you a prescription for medication or physical therapy, you can now be prescribed FDA-approved digital apps.

FDA 111

FDA Medicare Medicare Medicaid 111

Healthcare Dive

JUNE 13, 2022

Agency scientists found the shots to be similarly effective in kids as in older teenagers and raised no major safety red flags, documents published ahead of a meeting of agency advisers this week show.

FDA 130

FDA 130

The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

FDA 87

FDA Compliance Officers Compliance HIPAA 87

Healthcare IT Today

JANUARY 12, 2025

CES 2025 Announcements Circular announced Ring 2, a smart ring capable of detecting AFib through FDA-cleared ECG technology. HCPro launched its Provider Education Microlearning Series , which offers training on clinical documentation integrity, coding, and RCM.

Payment Systems 85

Payment Systems FDA Nurses 85

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.

US Department of Health and Human Services 190

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

Healthcare IT Today

JANUARY 3, 2025

Regulatory agencies like the FDA and EMA are increasingly proactive, recognizing AI’s potential to streamline trials while addressing ethical concerns, including minimizing patient exposure to ineffective treatments. There will be no in-between. That would send shockwaves through the whole pharma industry.

Pharmaceutical Industry 88

Pharmaceutical Industry FDA Compliance Regulatory Compliance 88

Dot Compliance

FEBRUARY 5, 2025

Batch Manufacturing Records (BMRs) document every step of the production process for each batch of a product. Raw Materials: Supplier information, quantity used, certificates of analysis, and traceability documentation. Equipment Calibration: Documentation of equipment calibration and maintenance.

Compliance 59

Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

Mobi Health News

MARCH 29, 2021

According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees. .

COVID-19 121

COVID-19 FDA Public Health 121

Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

FDA 52

FDA 52

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA.

FDA 60

FDA HIPAA Compliance 60

Dot Compliance

APRIL 17, 2025

Organizations in the life sciences industry that manufacture or distribute medical devices should consider ISO 13485 to: Meet regulatory requirements: Comply with stringent regulatory standards like FDA, CE marking, and others. This documentation is essential for traceability, verification, and regulatory compliance.

Regulatory Compliance 52

Regulatory Compliance Compliance FDA Medical Device Industry 52

Healthcare IT Today

JANUARY 15, 2025

Scientific studies have documented vulnerabilities in medical IoT (IoMT) devices, such as inadequate authentication, poor encryption protocols, and susceptibility to exploitation via remote code execution or leveraging adversary-in-the-middle (AiTM) attacks. However, these advancements come with significant cybersecurity challenges.

FDA 84

FDA Hospitals Ransomware Licensing 84

Mobi Health News

JUNE 30, 2023

Also, Augnito unveils its ambient technology for clinical documentation.

FDA 109

FDA 109

Jane Sarashon

FEBRUARY 13, 2025

Health Populi’s Hot Points: Physicians have become more familiar with various AI use cases that are helping reduce administrative burden, bolster cognitive processes, and streamline scribing, documentation, and notes. First, U.S.

Doctors 64

Doctors FDA Hospitals Bioethics 64

Dot Compliance

APRIL 11, 2025

This may include FDA regulations for medical devices or pharmaceutical products, EMA regulations for products sold in the European Union, or ISO standards for general quality management. Step 3: Develop a QMS Documentation Framework A strong documentation framework is essential for a functioning QMS.

Regulatory Compliance 52

Regulatory Compliance Compliance FDA 52

Dot Compliance

JANUARY 14, 2025

This is achieved through several key capabilities: Centralized Platform: An eQMS provides a centralized repository for all quality-related documents, procedures, and data. Automation: Many eQMS solutions automate routine processes, such as document approvals, task assignments, and data entry.

Compliance 59

Compliance Regulatory Compliance FDA 59

Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

FDA 52

FDA Compliance Officers Compliance Regulatory Compliance 52

HIT Consultant

NOVEMBER 17, 2024

The FDA has recognized the limitations of these devices noting that factors such as measurement location, distance of the sensor, individual physiological attributes and environmental conditions can all impact the reliable performance of NCITs.

Medical Device Industry 98

Medical Device Industry Hospitals FDA World Health 98

Bill of Health

APRIL 6, 2022

MDMA clinical trials are nearing completion and expected to result in FDA approval. In addition to benefits , adverse reactions have been documented. The benefits and drawbacks of macrodosing are now well documented. Oregon will begin accepting applications from businesses to run psilocybin service centers in January 2023.

FDA 219

FDA 219

Dot Compliance

JANUARY 29, 2025

It centralizes and streamlines tasks such as document control, nonconformance management, corrective and preventive actions (CAPAs), audits , and training. For example, automated document approval processes can significantly speed up the review and approval cycle. What Is an eQMS?

Regulatory Compliance 59

Regulatory Compliance Compliance FDA HIPAA 59

Mobi Health News

AUGUST 26, 2019

According to the recall document, the company didn't have FDA authorization to market the product.

FDA 100

FDA 100

Healthcare IT Today

FEBRUARY 2, 2025

Partnerships AI documentation and coding vendor Ambience Healthcare joined athenahealth’s Marketplace Program. GE HealthCare received FDA clearance for the latest version of Voluson Expert Series ultrasound systems. Only 14% of Americans are confident in their health plan choices, according to a survey from Softheon.

Hospitals 69

Hospitals FDA HIPAA 69