News & Analysis as of

Digital Health

FDA to Create New Digital Health Unit

by Knobbe Martens on

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

New legislation eases the way for telehealth providers in TX and signals increasing national alignment

by Dorsey & Whitney LLP on

New legislation recently signed into law in Texas paves the way both for digital health companies to expand, particularly direct-to-consumer (D2C) companies, and also potentially heralds an era of virtual care visits on a...more

Value-based health care: data & technology

by Ropes & Gray LLP on

Ira Parghi, Ropes & Gray health care counsel, discusses the increasing role that data and technology will play in a value-based health care world. __ There’s a lot going on when it comes to technology and health care. We...more

Payer/Provider Digital Health Investments Increase in Q1 2017

Last September, we noted that payers and providers were expected to become increasingly active digital health strategic investors given their challenges to improve margins and outcomes....more

First Quarter Venture Funding Bounces Back from Fourth Quarter Low

PricewaterhouseCoopers (PwC) and CB Insight recently released the results of its US MoneyTreeTM Report on U.S. venture funding for the first quarter of 2017. The report indicates that venture capitalists invested $13.9...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Potential HIPAA Pitfalls for Developers of Healthcare Apps

by Perkins Coie on

As federal and state governments struggle to address future healthcare regulation, demand for healthcare that is cheaper, better and faster continues to surge. Every day, new healthcare apps are being developed to respond...more

Health Alert (Australia) April 24, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 11 April 2017 - Medical Board Of Australia and Nuttall [2017] WASAT 58 - National Law - Professional misconduct - Advice - Lacking...more

Health Alert (Australia) March 6, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth . Administrative Appeals Tribunal 28 February 2017 - Nairn and National Disability Insurance Scheme...more

Health Alert (Australia) February 27, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Fair Work Commission 20 February 2017 - Renton v Bendigo Health Care Group [2017] FWC 921 -...more

Health Alert (Australia) February 13, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 3 February 2017 - Australian Nursing and Midwifery Federation v Royal Children's...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

Digital Health Solutions are Key to Success under Health Care Payment Innovations

by McDermott Will & Emery on

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more

Digital Health’s Perfect Storm of Regulators

by McDermott Will & Emery on

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the...more

21st Century Cures Act – Provisions Relating to Digital Health

by Ropes & Gray LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

More Digital Health Device Makers Expected to Seek FDA Clearance

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...more

Trump’s Impact on Digital Health: An Analytic Framework for Evaluating the Changing Landscape

by McDermott Will & Emery on

The promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

by McDermott Will & Emery on

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

Health Alert (Australia) December 12, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Circuit Court 5 December 2016 - Singh v Minister For Immigration & Anor [2016] FCCA 3061 - MIGRATION –...more

The 21st Century Cures Act and Its Effect on Digital Health

by Morgan Lewis on

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

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