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FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Big Data Creates New Opportunities for Health Care Entities

Big Data — the ability to collect, process, and interpret massive amounts of information — has reached health care. Technology has created new business opportunities for health care entities — covered entities, business...more

Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more

Tapping Into the Big Value of Health Care Big Data

In This Issue: - Executive Summary - Improving Care by Tapping Into the Data Goldmine - Big Opportunities Available in Big Data - Government Programs Supporting the Use of Big Data -...more

“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

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

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

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

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

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

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Preparing for a Data Breach – What to Know about Breach Notification

Data breaches are at the forefront of the news, and many companies, including those dominant in the health care industry, have found themselves front and center in the headlines. Although recent news stories have focused...more

Locke Lord QuickStudy: Attention, Health Insurers: Unique Encryption Requirements in NJ

Setting a new standard for encryption, New Jersey has enacted a new law (P.L. 2014, c. 88, codified at N.J. Stat. Ann. §§ 56:8-196 - 56:8-198) effective August 1, 2015, requiring health insurance carriers authorized to issue...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Cyber Attackers Reach Anthem, Health Care Providers Seen As Vulnerable

Anthem, one of the nation’s largest health insurers, announced last Wednesday that it had been attacked by cyber hackers and that personal information for as many as 80 million individuals had been compromised....more

Responding to the Anthem Cyber Attack

Anthem Inc. (Anthem), the nation’s second-largest health insurer, revealed late on Wednesday, February 4 that it was the victim of a significant cyber attack. According to Anthem, the attack exposed personal information of...more

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

OMB Receives Final Rule Permitting Disclosure To NICS --According to reginfo.gov, the White House Office of Management and Budget received a final rule from HHS that would modify the HIPAA Privacy Rule to expressly permit...more

Pressure Points: OCR Enforcement Activity in 2014

During 2014, the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services initiated six enforcement actions in response to security breaches reported by entities covered by the Health Insurance...more

Employers: What the Anthem Breach Means to You

On Feb. 4, 2015, Anthem announced a data breach involving the personal information of more than 80 million individuals resulting from what it characterized as a sophisticated, targeted cyber-attack. Group health plans may be...more

Is 2015 the Year of Data Protection?

The growing frequency, impact and sophistication of cyberattacks in the U.S. and abroad have highlighted the need to address America's lack of a unified federal cybersecurity framework. No single congressional committee or...more

SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in...

On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more

Anthem Breach – Implications for What Constitutes “Reasonable” Security Procedures Under California Law.

Upwards of 80 million Americans may be affected by the Anthem data breach.  According to Anthem’s press release, the hackers gained access to the names, birthdays, medical IDs/social security numbers, street addresses, email...more

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