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“Bring Your Own Device” To Work Programs: Regulatory and Legal Risks and How To Minimize Them

If you’ve ever left your mobile phone on an airplane, in a restaurant, or somewhere other than in your possession, you know it’s frightening enough to think of losing the device itself, which costs a premium, as well as your...more

UK Information Commissioner’s Office (ICO) Receives Power to Audit National Health Service

The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more

Medical Device Market to Reach $361 Billion

According to an article in Medical Design Technology, Kalorama Information’s 2014 report on The Global Market for Medical Devices estimated that the global market for medical devices was expected to reach $361 billion by...more

Scanadu: the Medical Tricorder from Star Trek

For those familiar with the television show Star Trek, many may remember the Tricorder, a device that Dr. “Bones” McCoy used to wirelessly scan a patient to assess the individual’s medical status. The California...more

Federal Court Decision Demonstrates Ongoing Challenges Faced by Plaintiffs in Data Breach Litigation

On February 11, 2015, the U.S. District Court for the Southern District of Texas dismissed a class action complaint against the St. Joseph Health System arising out of a data security breach that occurred after hackers...more

Office of Civil Rights Delays Phase 2 Audits

The Office of Civil RIghts (“OCR”) recently announced that Phase 2 of the HIPAA audits would be further delayed because the audit portals and project management tools that are needed to initiate the audit process are not...more

New Jersey Imposes Unique Encryption Requirements

Effective August 1, 2015, New Jersey will require health insurance carriers authorized to issue health benefit plans in New Jersey to encrypt personal information that they store electronically....more

Health Update - February 2015

Cyber Risk Insurance Policies: What You Need to Know - Editor’s Note: As data breach incidents and related cyber risks continue to increase and gain publicity—and government agencies become more actively involved in...more

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

ProNerve Holdings, LLC, A Colorado Based Provider of Intraoperative Neurophysiologic Monitoring (IOM) Files for Chapter 11...

On February 24, 2015, ProNerve Holdings, LLC and 8 affiliated companies filed voluntary chapter 11 petitions in Delaware. The case is docketed at 15-10373, and has been assigned to The Honorable Kevin J. Carey....more

Generic Drug Price Hike Investigations Target Lannett

Since we last reported on state and federal investigations into recent generic drug price increases, the investigations have moved forward against Philadelphia-based Lannett Co. On November 20, a Senate healthcare...more

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

Pharmaceutical Uses Acquisition To Make Itself More Competitive

For companies looking to become more competitive in the marketplace, maintaining a lookout for potentially valuable acquisitions is an important task. Acquisitions, when entered into strategically and with proper legal...more

The Employment Law Authority - January/February 2015

In This Issue: - High Tech, High Risk: Protecting Health Plan Data: Recent Cyber Attack Reminds Employers to Take Swift Action - EEOC FY 2014 Statistics Are Here: What Do They Mean for Employers? - State...more

Also In the News - Data, Privacy, & Security Practice Report - February 2015 #3

White House Holds Summit On Cybersecurity And Consumer Protection — On February 13, 2015, leaders from throughout the country representing sectors with a stake in cybersecurity and consumer protection issues convened at...more

FDA Releases Planning Board's Report on National Medical Device Postmarket Surveillance System

FDA has released the Medical Device Postmarket Surveillance System Planning Board’s report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, which outlines recommended steps...more

HIPAA Compliant Technology and the Importance of Encryption

We welcome this guest blog by Gene Fry, Compliance Officer, Scrypt, Inc. The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data. This means that any...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

FDA Lawyer Epiphany: Lawyers Helping FDA

So I had an epiphany last night—I was thinking about why more FDA lawyers do not get involved in helping Congress or FDA with developing legislation, regulations, and guidances to help FDA do its business....more

Blog: Deadline Approaching for Reporting 2014 HIPAA Breaches

All covered entities that discovered security breaches under the Health Insurance Portability and Accountability Act (“HIPAA”) in 2014 should be aware of an upcoming reporting deadline. ...more

Washington Healthcare Update

This Week: Upcoming Hearing: HHS Sec. Burwell Appearing Before E&C Committee on FY2016 Budget... CMS Issues 2016 Payment and Policy Updates for Medicare Health and Drug Plans... CMS Releases Improved Rating System for Nursing...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

EU Art. 29 Working Party Letter on Health Data and Apps

The EU Article 29 Working Party (“WP29”) has published a letter to the European Commission (“EC”) on the scope of health data in relation to lifestyle and well-being apps, following the EC’s Working Document on mHealth and...more

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