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Health Care Providers Health Insurance Portability and Accountability Act (HIPAA) Life Sciences

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh...

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Heather Matthews and Matthew Roberts welcome Ira Bedenbaugh and Randi Branham of Elliott Davis, where they provide consulting services to physicians, hospitals, and other health care entities. Our guests share the latest...more

BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

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Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Quarles & Brady LLP

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

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Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

Holland & Knight LLP

Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws

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In this episode of "Counsel That Cares," HIPAA and healthcare privacy attorneys Beth Pitman and Shannon Hartsfield dissect the highly publicized Dinerstein v. Google case. They address the implications and concerns of sharing...more

Burr & Forman

Hot Topics in Health Care July 2023  

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Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

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While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Akerman LLP - Health Law Rx

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more

Fenwick & West Life Sciences Group

A Complex Regulatory Landscape Emerges for Telemedicine

Every year, Rock Health surveys the digital health landscape, noting the changing trends related to adoption by providers, patients and payers of these innovative new technologies....more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

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Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

MoFo Life Sciences

Prevent A Clinical Trial From Turning Into A Criminal Trial

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On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

Hogan Lovells

A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

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Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more

Quarles & Brady LLP

Recent Updates in Data Privacy & Security for Health Care Entities

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March was a busy month for data privacy and security, especially as it relates to health care entities. To help keep you up to date with the changes, we’ve included a few highlights for you below... ...more

Orrick, Herrington & Sutcliffe LLP

Year-End Roundup for Health Data Privacy: What Life Sciences and Healthcare Companies Need to Know for 2022

We expect many of the trends of 2021 in health data privacy to continue to pick up steam this year. See below for six noteworthy trends that life sciences and healthcare companies should continue to keep an eye on in 2022: ...more

Manatt, Phelps & Phillips, LLP

[Webinar] Building Effective Health Care Partnerships: A Joint Venture Primer - November 3rd, 12:00 pm - 1:00 pm ET

A New Manatt Health Webinar Gives You a Step-by-Step Guide to Creating Joint Ventures That Drive Growth, Optimize Profits and Improve the Patient Experience. Joint ventures are becoming a mission-critical strategy for an...more

Manatt, Phelps & Phillips, LLP

Telehealth: Regulation, Compliance, Audit and Investigation

I. Introduction - Use and acceptance of telehealth technologies have grown very substantially since the start of the COVID-19 pandemic. This growth has been substantially facilitated by waivers and relaxations of existing...more

Orrick, Herrington & Sutcliffe LLP

Cybersecurity and Privacy Threats and Risks for Life Sciences and Healthcare Companies

Attacks on the life sciences and healthcare sectors (healthcare providers and health technology, medical device, pharmaceutical and biotechnology companies) increased significantly in the last year, including at the World...more

Troutman Pepper

FDA Launches Digital Center of Excellence and ONC Updates HIPAA Security Risk Assessment Tool

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Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more

McDermott Will & Emery

CCPA Amendment Update: California Legislature Approves Exceptions for HIPAA De-Identified Information and Other Health Data

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On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...more

BakerHostetler

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

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The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more

McDermott Will & Emery

Special Report - 2019 Digital Health Year in Review - January 2020

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Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

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On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

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The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Hogan Lovells

Telehealth promises faster, more convenient access to health care services

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From mobile apps for monitoring medications to virtual appointments with specialists, telehealth services are creating new levels of convenience for providers and patients. But as companies digitize more pieces of the health...more

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