Communications & Media Science, Computers & Technology Health

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New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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

OCR levies first fine ever directly against business associate

Our predictions that the Office for Civil Rights (OCR) will become more aggressive with audits, investigations, and fines against HIPAA business associates has come true. On June 24, 2016, the OCR announced that it has...more

The Rocky Road of Evaluation for Digital Health Tools

Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter. (Add this post to the noise!) While some may decry the comparison, there is a lot we can learn from that...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

PowerPoint Slides: Could My Company's Website Violate the Americans with Disabilities Act?

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Webinar: Could My Company's Website Violate the Americans with Disabilities Act? [Video]

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

Health IT Bill Passes Congress, Opening Affordable Broadband Access to Rural Nursing Homes

In a late night voice vote on June 7, 2016, the Rural Health Care Connectivity Act finally passed the full Senate. Among other things, the new law promises to open up opportunities for both the long-term care industry in...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

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