Tag: health IT

All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness:  Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout.  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products […]

Implications of the Cybersecurity Bill for the Health Care Industry

*This post is co-authored by Vince Sampson On Tuesday the Senate passed the Cybersecurity Information Sharing Act (CISA).  The House had passed a similar bill, the Protecting Cyber Networks Act, in April of this year.  The Act comes in the wake of many large scale data breaches, such as that suffered […]

General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present a low risk to users. Cooley recently collaborated with Worrell to develop […]

Lawmakers release new version of 21st Century Cures legislation

Yesterday, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative.  This draft is the latest step in the Committee’s year-long attempt to accelerate new medical innovations and improving the way they are brought to market.  According […]

Class Action Following Health Information Data Breach

As we discussed in our previous post, Premera Blue Cross (Premera) recently revealed that it suffered a massive data breach potentially exposing the personal data of 11 million customers.  On Thursday Premera was hit with a proposed class action lawsuit in Washington federal court accusing it of negligence associated with the […]

Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of 21st Century Cures, a significant report from the Federal Trade Commission (FTC) […]

Another Large Scale Data Breach Announced by Premera Blue Cross

Premera Blue Cross revealed Tuesday it was hit by a sophisticated cyber attack potentially exposing personal data for approximately 11 million of its members including members, employees and others with whom it does business, dating back to as early as 2002.  The insurer said its investigation revealed the initial malware attack occurred on May […]