Health Science, Computers & Technology Communications & Media

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Yuba Sutter Medical Center Hit With Ransomware

Yuba Sutter Medical Center in California (Yuba Sutter) has notified its patients that it has suffered a recent ransomware attack that caused parts of its network to be incapacitated. As a result, patient files were unable to...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Manatt Digital - September 2016

Digital Health Continues to Grow - Investment into the digital health market topped $4.5 billion in 2015, and we are seeing an acceleration of investment in 2016. According to StartUp Health, investment into the digital...more

Health Care E-Note - September 2016

In an article published in the September 2016 MASA Newsletter, Jim Hoover and Angie Cameron Smith discuss how physicians should properly respond to subpoenas and requests for patients’ health information. They stress how...more

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

Locky Ransomware Continues to Hit Health Care Entities

FireEye Labs has reported that the Locky ransomware continues to hit the health care industry hard, and has increased in the month of August. Although the telecommunications, manufacturing and aerospace/defense...more

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

CMS Issues Warning to Nursing Homes Regarding Abuse of Residents Via Social Media

On August 5, 2016, the Centers for Medicare & Medicaid Services (CMS) issued guidance to nursing homes in a letter to state survey agencies that addresses nursing homes’ obligations to protect residents. The Letter focuses on...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

JCAHO Delays Decision Allowing Physicians To Text Orders

We previously reported that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) lifted its ban on allowing health care providers to use texts for physician orders....more

FTC Mobile Health Guidance

On April 5, 2016, the Federal Trade Commission (FTC) released new guidance for mobile apps directed towards providing health-related services and information. This guidance was developed with numerous other agencies,...more

Illinois Revises Data Privacy Statute

Earlier this year, Illinois enacted a number of changes to the Illinois Personal Information Protection Act (“PIPA”). The amendments to PIPA, among other things, expand the definition of personal information subject to...more

Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

Report Warns Providers of HIPAA Violations When Responding to Negative Online Reviews

ProPublica, a public interest investigative newsroom, recently identified more than 3,500 one-star medical reviews on Yelp in which patients complained about privacy issues. ProPublica determined that “in dozens of instances,...more

OCR Announces First HIPAA Enforcement Action against a Business Associate

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health...more

Technology Must Be A Priority for Senior Living Communities

A recent panel at the Chicago Senior News Chicago Summit discussed the tendency of senior housing developers to spend money on the wrong priorities. In particular, they noted that money spent on technology should be...more

New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have...

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf. Individuals who are blind or have low vision may require assistive devices and specialized software to access the...more

Facebook and HIPAA: Strange Bedfellows

As a social media user, you may have experienced Facebook’s targeted advertising. Mere moments after searching for a specific item on Google or visiting another website, your Facebook ads reflect your recent browsing history....more

Recent Enforcement Action: Business Associates Not Off the Hook

Despite the fact that Business Associates have been directly subject to and liable under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (HIPAA) since February 18, 2010 the...more

BYOD Risks under HIPAA – Does Your HIPAA Compliance Program Adequately Address the Ever Increasing Use of Portable Electronic...

Many U.S. employers are now allowing employees to use their own personal handheld devices and laptop computers for work-related purposes. As the age of employer-provided devices is coming to an end and “bring your own device”...more

Lessons learned from "Health Tech Innovators" conference

Allen & Overy was delighted to be involved in the recent London Technology Week event called “Health Tech Innovators”. ?Organised by Tech London Advocates, MedCity and DigitalHealth.London, the event brought together...more

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