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New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

Also In the News - Data, Privacy, & Security Practice Report - May 2016 #2

K&S Client Alert: Third Try Is A Charm: Defend Trade Secrets Act Of 2015 Enacted Into Law—For the third consecutive year, Congress introduced legislation to create a federal civil cause of action for trade secret...more

Illinois Enacts Sweeping Changes to the Illinois Personal Information Protection Act

On May 6, 2016, Illinois joined a growing number of states that have strengthened their data breach notification requirements and expanded the definition of protected personal information. Effective January 1, 2017, HB1260...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

Check Your Inbox: OCR Continues to Verify Entity Contact Information for Phase 2 HIPAA Audits

Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR...more

EEOC Issues Final Rules on Employer Wellness Programs

On May 16, 2016, the Equal Employment Opportunity Commission (EEOC) issued two final rules describing how employer wellness programs must comply with Title I of the Americans with Disabilities Act (ADA) and Title II of the...more

Newest Ponemon study released on health care data breaches

The Ponemon Institute has recently released its Sixth Annual Benchmark Study on Privacy & Security of Healthcare Data. The study has included business associates for the past two years. The study included information received...more

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

Recent Settlements and Upcoming Audits Highlight the Continuing Need to Focus on Core HIPAA Compliance Measures

Recent settlements and initiatives conducted by the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services highlight the continuing need for focus on compliance with the privacy and security...more

Intermedix data breach class action case dismissed

We previously reported that Intermedix was sued in a class action lawsuit regarding the data breach involving millions of patient records....more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

Also In the News - Data, Privacy, & Security Practice Report - May 2016

OCR Releases Guidance On Data Security Incident Preparedness—On May 3, 2016, the Office for Civil Rights (“OCR”) within the U.S. Department of Health & Human Services released its cyber-awareness monthly update on the topic...more

Superior Court of Pennsylvania Denies Data Breach Class Certification

In an encouraging development for data breach defendants, the Superior Court of Pennsylvania recently affirmed a trial court decision rejecting class certification in a suit filed against two Medicare programs for losing a...more

Health Law Insights Newsletter - Issue 9 - May 2016

NATIONAL - Medicare Proposes New Part B Payment System - The Center for Medicare and Medicaid Services (CMS) on April 27 proposed a new rule that would transform Medicare Part B reimbursement to practitioners into...more

Settlements reached for PHI Disclosures

In the last two months, the U.S. Department of Health and Human Services (“HHS”) announced two settlement agreements involving the disclosure of protected health information ("PHI"). In both instances, the health care...more

FBI Warns of the Rise in Ransomware

On April 29, 2016, the Federal Bureau of Investigation (FBI) released a warning regarding the increase in ransomware cyberattacks. During 2015, law enforcement saw an increase in ransomware attacks, particularly against...more

Joint Commission lifts ban on physicians texting patient orders

The Joint Commission, which is the national accrediting organization for health care organizations, has long banned physicians using text messages to place orders for patient care due to data security concerns. In 2011, the...more

Help! They've got Grandma's Data and They're Holding it for Ransom!

Imagine if you started to open a resident’s file on your computer and this message came up on your screen against a red background...more

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the...more

OCR Updates HIPAA Audit Protocol for Phase 2

Recently, the Office of Civil Rights (“OCR”) provided an updated protocol that it will use when assessing compliance with HIPAA rules. OCR recently began Phase 2 of its HIPAA compliance audits, extending coverage of these...more

Bipartisan House Bill Would Elevate Chief Information Security Officer At HHS

On April 26, 2016, House Representatives Billy Long (R-MO) and Doris Matsui (D-CA) introduced the HHS Data Protection Act, legislation aimed at improving cybersecurity at the Department of Health and Human Services (“HHS”). ...more

Joint Commission Ends Ban on the Texting of Physician Orders

In the Joint Commission Perspectives May 2016 edition, the Commission reversed its 2011 position prohibiting clinician texting of patient orders within accredited health care institutions, stating technological advancements...more

Fourth Circuit Affirms Insurance Coverage for Cyber Claim Under CGL Policy

In a decision issued April 11, the Fourth Circuit added to a small but growing body of case law across the country finding coverage for cyber claims under traditional general liability insurance policies. In Travelers...more

Expansion of HIPAA audit program now underway

As detailed in our latest webinar, “Daunting but doable: Preparing for the next round of HIPAA audits,” the Office for Civil Rights (OCR) has begun implementing the first full-phase HIPAA audit program. The 2009 HITECH Act,...more

Increased Ransomware Attacks and Phase 2 HIPAA Audits: Two Closely-Related Issues for Long Term Care Providers

Long Term Care Provider Data Targeted and Held Hostage by Malicious Software - Long Term Care (LTC) facilities are increasingly targeted by criminals who seek to profit by infecting LTC computer systems with ransomware. ...more

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