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Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug...more

Medical devices and cybersecurity: FDA calls for comprehensive risk management programs

The Food and Drug Administration (FDA), with the issuance of its recent 2016 Draft Guidance “Postmarket Management of Cybersecurity in Medical Devices,” continues to step up its involvement with medical devices having a...more

Class Action Lawsuit Filed Against Fitbit

Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the...more

OCR Kicks Off HIPAA Audits After Issuing Two Major Settlements

On March 21, 2016, the HHS Office for Civil Rights (OCR) launched phase two of its much-anticipated audit program for covered entities and business associates. The announcement comes in the wake of OCR's issuance of two major...more

Navigating the Regulatory Issues of 3D Printing

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing...more

Are Drug Manufacturers Pulling A Fast One?

A new report criticizing pharmaceutical companies for releasing incomplete data about the side effects of certain medications should raise a red flag for consumers. The report, issued February 10, 2016, describes...more

Massachusetts Legislature Reaches Compromise on Opioid Legislation

On March 10, the Senate voted unanimously to pass a bill that offers long-awaited measures aimed at tackling the state’s growing opioid abuse crisis. After House approval the previous day and seven weeks of conference...more

After a Strong Enforcement Presence in 2015, OCR Starts 2016 with a $239,000 Civil Money Penalty Judgment

It has been a busy winter for the US Department of Health and Human Service, Office for Civil Rights (“OCR”). Since November 2015, the agency has announced three settlements and one civil money penalty judgment amounting to...more

California Data Breach Report Defines “Reasonableness” Standard for Data Protection

Nearly three in five Californians were victims of a data breach in 2015, according to a report released by state Attorney General Kamala D. Harris. The report adopts minimum standards of ''reasonable security'' for personal...more

Health Apps and HIPAA: OCR Publishes New Guidance For Health App Developers

OCR’s guidance presents hypothetical scenarios and key questions to help app developers determine when they are subject to HIPAA regulations. On February 11, the Department of Health and Human Services’ Office for Civil...more

[Webinar] Medical Mobile Apps: An Overview of the Regulatory Environment - March 16th, 12pm, Central Time

With mobile platforms more user friendly, and with computers, tablets and smartphones becoming more powerful, we see an increase in the offering of apps. Some of these apps are specifically targeted to assist individuals in...more

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

HHS Fact Sheet on Your Employees’ and Clients’ Rights under HIPAA to Access their Health Information

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, contains extensive rules designed to limit access by non-health plan entities to certain individually identifiable health...more

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

Developments in Cybersecurity: Privacy Laws, Hacking Beyond Customer Data, and Communicating with Corporate Boards

I. Legal Exposure to Federal and State Privacy Laws - A. Federal Statutes and Enforcement - 1. Federal Trade Commission Act, 15 U.S.C. §§ 41-58 - The Federal Trade Commission (FTC) has emerged as the leading...more

Nearly 50 Million Records Breached in California Since 2012

Earlier this month, the California Attorney General’s Office released the 2016 Data Breach Report covering years 2012 through 2015 for the State of California (the “AG’s Report”). The AG’s Report reveals that 557 data...more

At A Glance: De-Identification, Anonymization, and Pseudonymization

De-identification of data refers to the process used to prevent personal identifiers from being connected with information. The FTC indicated in its 2012 report Protecting Consumer Privacy in an Era of Rapid Change:...more

California by the Numbers (Part 1): 24 Million Compromised in 2015

California Attorney General Kamala Harris has released a report of the data breaches that have been reported to her office from 2012 until 2015. Although the California data breach notification law took effect in 2003,...more

Radiology Regional Center paper medical records fall out of back of truck

In the category of “Seriously—not again?” Radiology Regional Center, located in Fort Myers, Florida, notified over 480,000 individuals and the Office for Civil Rights that their medical records, including names, dates of...more

Inadequate OCR Technology and Policy Result in Few Consequences for Repeat HIPAA Violators

The Office for Civil Rights within the U.S. Department of Health and Human Services (OCR) is the federal agency tasked with enforcing the Health Insurance Portability and Accountability Act (HIPAA). HIPAA, as most folks...more

New FDA Draft Guidance On Medical Devices Would Notify Public Of Risk Before Analysis Or Confirmation

On December 31, 2015, the FDA released a draft policy which would alter how and, more significantly, when the public is notified of a potential risk associated with a medical device that has already been approved for the...more

Opioid Use on Front Burner at FDA Now That Congress Has Intervened

The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers....more

Hollywood Presbyterian Concedes to Hacker’s Demands in Ransomware Attack

In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack...more

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...more

Companies can insure against cyber ransom

National Public Radio and other news outlets are reporting that a Los Angeles-area hospital recently paid a $17,000 ransom (in the form of 40 bitcoins) to hackers to unencrypt its computer networks, which had been held...more

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