News & Analysis as of

Health Information Technologies Risk Management

Morrison & Foerster LLP

FTC Looks to Leverage PADFAA Enforcement to Help Limit Exposure of Consumer Data

In recent comments, Commissioner Holyoak signaled that the Federal Trade Commission will prioritize enforcement of the Protecting Americans’ Data from Foreign Adversaries Act (PADFAA), a law that empowers the FTC to police...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Troutman Pepper Locke

Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, host Brett Mason is joined by Alison...more

McDermott Will & Schulte

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

Foley Hoag LLP - Security, Privacy and the...

HHS-OIG Releases Cybersecurity Toolkit

On March 26, 2024, the HHS Office of Inspector General (OIG) released a cybersecurity toolkit for HHS leaders to help them plan and deploy information systems in response to disasters and public health emergencies. The...more

Fenwick & West LLP

Washington’s My Health My Data Act – A Roadmap for Compliance

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What is the new Washington My Health My Data Act (MHMDA)? MHMDA aims to provide stronger privacy protections for “consumer health data” by: - Requiring additional disclosures for the collection, use, and sharing of...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

Jackson Lewis P.C.

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

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Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more

Bradley Arant Boult Cummings LLP

The Imperative of Cyber Preparedness: The Power of Tabletop Exercises

In an age where digital connectivity is rapidly advancing, cybersecurity has become an inescapable concern for organizations across industries. With cyber threats ranging from data breaches to ransomware attacks, it is...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

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Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Nelson Mullins Riley & Scarborough LLP

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

NAVEX

What Risk Managers Can Learn From the Health Care Industry

NAVEX on

The COVID-19 pandemic had the silver lining of accelerating the digital transformation of countless industries, and as the dust settles over health care’s own evolution, risk managers will need to navigate an ever-more...more

Health Care Compliance Association (HCCA)

[Event] 26th Annual Compliance Institute - March 28th - 31st, Phoenix, AZ

The primary educational and networking event for healthcare compliance professionals - As our flagship healthcare compliance conference, HCCA’s Compliance Institute (CI) has been providing educational resources and...more

Akerman LLP - Health Law Rx

Providers: Cyberattacks Are Still Coming–Are You Prepared?

Cyberattacks against healthcare providers accounted for 79% of all reported data breaches in 2020. (See here). The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and...more

Woods Rogers

Patient’s Right to Access Medical Records: HHS-OCR Targets Healthcare Providers Large and Small

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Elizabeth Barry Heddleston Associate Now is a great time for healthcare providers to assess their compliance with HIPAA’s right of access requirements. Not only is this a hot area of enforcement, patients’ rights to access...more

Health Care Compliance Association (HCCA)

Compliance Perspectives: The Ethics of Data

Digitalization and the proliferation of apps have changed the relationship in healthcare between data, the patient and provider, explains Hema Lakkaraju, CEO and founder of Hayag Corporation. It is often unclear who is...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

Sheppard Mullin Richter & Hampton LLP

Information Blocking And The Right To Access Initiative: Why Patients Struggle to Obtain their Medical Records and what the Office...

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial,...more

Health Care Compliance Association (HCCA)

Compliance Perspectives: Providing Patient Access to Personal Health Data

When it comes to HIPAA everyone knows about the risks of disclosing Personal Health Information (PHI) improperly. Also important, but often overlooked, is the need to ensure that when patients want access to their data that...more

Robinson+Cole Data Privacy + Security Insider

Cybersecurity Risks in Medical Devices Discussed at Recent FDA Meeting

The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #191 – Trying to Protect Your Medical Information—Let’s Ask Questions About Data Security

In the top three of the list of highly sensitive personal data to be concerned about is our medical information. It’s so sensitive because it is so personal. It used to be that our medical information was located in paper...more

Troutman Pepper Locke

Health Sector Cybersecurity Guidance Provides Best Practices Applicable Across Industries

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While cyberattacks continue to increase in number, health care organizations face some of the greatest risks. According to the Health Sector Coordinating Council (HSCC) — a coalition of industry associations that operates in...more

Carlton Fields

2018 Was A Record Year in HIPAA Enforcement

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services recently announced that 2018 was a significant year in Health Insurance Portability and Accountability Act (HIPAA) enforcement activity. ...more

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