Archives: Software

Subscribe to Software RSS Feed

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part III

Legislative Exclusions of Software (21st Century Cures Act) The 21st Century Cures Act (Cures Act), signed into law on Dec. 13, 2016, was designed to accelerate medical product development and bring new innovations faster and more efficiently to patients who need them. Interesting aspects of the Cures Act include that it streamlines FDA procedures to … Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part II

The Promise of Digital Therapeutics According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior. The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Sepah et al. defined “digital therapeutics” as “evidence-based behavioral … Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part I

Introduction More Americans than ever before are suffering from mental and emotional distress. In the United States, the mental health problem is exacerbated by issues across infrastructure, government and culture. However, because the resources for those living with mental health issues are constrained,[1] startups could have a big impact. In particular, we believe that digital … Continue Reading

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology Considerations

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit addresses the proliferation of digital technology and software being used in the medical community, specifically in medical devices. As … Continue Reading

Major 101 Decision – Enfish v. Microsoft

Today in Enfish v. Microsoft, the Federal Circuit held software claims patent eligible, reversing the district court’s grant of summary judgment on 101. This is a major decision because it is only the second since Alice where the Federal Circuit has held patent claims eligible (DDR being the first). Further, the case heavily emphasizes that … Continue Reading

Epic Verdict in Trade Secrets Case

Last week, a federal jury in Wisconsin awarded almost $1 billion to Epic Systems Corporation in its trade secrets case against Indian consulting company Tata Consulting Services, Ltd., and its American unit, Tata America International Corporation. Epic provides software for medical groups, hospitals, and integrated health care organizations. Tata was hired by one of Epic’s … Continue Reading
LexBlog