News & Analysis as of

Electronic Medical Records Regulatory Requirements

McDermott Will & Schulte

European Health Data Space Regulation enters into force

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

McDermott Will & Schulte

ASTP’s HTI-2 Proposed Rule Would Add and Expand Information Blocking Exceptions

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Troutman Pepper Locke

New California Law Imposes Significant Data Management Requirements for Sensitive Health Data

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On January 1, California's Assembly Bill No. 352 (AB 352) went into effect, introducing significant changes to the handling and sharing of sensitive health information — particularly information related to reproductive health...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 19th, Charlotte, NC

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

J.S. Held

Challenges of Telemedicine & Digital Health Records: Unique Problems Impacting Casualty Claims & Injury Assessment

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While telemedicine visits and digital health records have brought about significant improvements in healthcare accessibility and efficiency, they also present unique challenges in the context of casualty claims and injury...more

Troutman Pepper Locke

Storm Clouds Form Offshore Under Updated Florida Electronic Health Records Exchange Act

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Background - On July 1, an amendment to the Florida Electronic Health Records Exchange Act (the Act) will go into effect. The Act focuses on information safety and sets forth stringent requirements that prohibit health...more

Robinson+Cole Health Law Diagnosis

ONC Information Blocking Data Show Majority of Claims Against Health Care Providers

On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking...more

Robinson+Cole Data Privacy + Security Insider

Reporting of Breaches Under 500 Due by March 1

HIPAA requires covered entities and business associates to report to the Office for Civil Rights (OCR) all breaches of unsecured protected health information when the incident involves fewer than 500 individuals no later than...more

Health Care Compliance Association (HCCA)

[Virtual Event] Atlanta & Charlotte Regional Healthcare Compliance Conference - January 14th, 8:25 am - 4:30 pm EST

First-class compliance training from your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the latest news in regulatory...more

Pullman & Comley - Connecticut Health Law

ONC Releases New Guidance FAQs on Information Blocking

Recently, the Office of the National Coordinator for Health IT (ONC) issued a new series of helpful FAQs related to its information blocking regulations. The new FAQs cover a wide range of topics, including the content and...more

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

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The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

Jones Day

California Attorney General Issues Bulletin on Health Data Breach Reporting Requirements

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The California Attorney General ("AG") has issued guidance reminding health care providers of their duty to report health care data breaches and to comply with other state and federal data privacy laws....more

Butler Snow LLP

The Information Blocking Rule: Considerations for Health Care Providers

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On May 1, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) published its final rule, commonly referred to as the “Information Blocking Rule,” implementing certain provisions of the 21st...more

Pullman & Comley - Connecticut Health Law

Information Blocking FAQs – The April 5th Implementation Deadline Has Passed; What Providers Need to Know

Monday, April 5th, marked the deadline for compliance with the information blocking regulations implemented by the Office of the National Coordinator for Health IT (ONC).  As a follow-up to our earlier FAQs on these new...more

Bricker Graydon LLP

Information blocking compliance – Are you ready for April 5?

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On April 5, 2021, covered actors, which include health care providers, certified health information technology developers, and health information networks and exchanges, will be prohibited from taking any action that is...more

Lippes Mathias LLP

New ‘Information Blocking’ Compliance Obligations Take Effect April 5, 2021

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The 21st Century Cures Act (Act) and a recently adopted final rule by the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services will now prohibit...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Charlotte, NC - January 15th, 8:25 am - 5:30 pm EST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Bricker Graydon LLP

HHS releases final rules on interoperability and information blocking

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On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

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A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

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In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

McDermott Will & Schulte

ONC Proposes to Define Conduct That Is Not Information Blocking under the Cures Act

The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more

Troutman Pepper Locke

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

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A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Jones Day

Artificial Intelligence and Health Care—Key Regulatory Considerations for U.S. Operations

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The Situation: Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes. The Issue: The health care industry, including the provision of health...more

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