News & Analysis as of

Electronic Medical Records Regulatory Oversight

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #1

News Briefs - Biden Executive Order Aims to Bolster AI Security in Healthcare - The Biden Administration issued what it's calling a "landmark" executive order designed to help channel the significant promise and manage the...more

McDermott Will & Emery

Top Takeaways | 2023 PPM-ASC Symposium | Leveraging Data Collaborations for Revenue Growth

McDermott Will & Emery on

In this session, the panelists discussed the successes and challenges of a data collaboration between Gastro Health and Lynx.MD, and provided real-world insights into how a physician platform can harness its data to enhance...more

ArentFox Schiff

OIG Declines To Challenge Debt Cancellation and Restructured Financial Arrangements Between Health System and FQHC “Look-Alike”...

ArentFox Schiff on

In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more

Bricker Graydon LLP

HHS OCR announces results of most recent round of HIPAA audits

Bricker Graydon LLP on

On December 17, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its Industry Report on the HIPAA audits it conducted in 2016 and 2017. OCR found widespread noncompliance with...more

Polsinelli

FCA Targets Areas For 2020 and Increased Use Of The Voluntary Disclosures

Polsinelli on

Jody Hunt, Assistant Attorney General for DOJ’s Civil Division, and Michael Granston, Deputy Assistant Attorney General, Commercial Litigation Branch, spoke recently about False Claims Act (“FCA”) enforcement at the Federal...more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

Burr & Forman on

Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

Mintz - Health Care Viewpoints

Regulators Look to Increase Interoperability and Patient Access to Health Data

Federal regulators are flexing their regulatory muscle to accelerate a long-desired but often elusive goal: the interoperability of health information technology (health IT) systems. Interoperability refers to the ability of...more

Robinson+Cole Data Privacy + Security Insider

Proposed New Rules Submitted to OMB on Information Blocking

On September 17, 2018, the federal Office of the National Coordinator for Health Information Technology (ONC) submitted proposed new rules to the Office of Management and Budget (OMB), entitled, “21st Century Cures Act:...more

Troutman Pepper

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

Troutman Pepper on

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

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Winstead PC

Is it HIPAA or HIPPA? Either way, it still applies.

Winstead PC on

I have negotiated hundreds of SaaS agreements for dozens of software companies and I always hated when the company on the other side was a healthcare provider. Invariably, they would bring up Protected Health Information...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

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