Digital Health

News & Analysis as of

21st Century Cures: A Closer Look

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

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

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

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

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

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

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

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

Expanding Capacity for Health Outcomes (ECHO) Act Requires Exploration of Digital Health Opportunities

On December 6, 2016, the US House of Representatives passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the US Senate on November 29, 2016. The ECHO Act seeks to...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and...

INTRODUCTION - 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...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

Top Trends in H1 2016 Digital Health Investments

A few months ago, following our fifth annual Digital Health Summit, the attendees made some predictions about product development and investment in the rapidly growing sector. Now that we are more than halfway through the...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

Does Digital Health Need Reimbursement?

One of the most talked about topics when it comes to digital health is the reimbursement under various third-party payer programs. Most notably, telemedicine and remote monitoring have received a lot of attention, and the...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

Top Takeaways from Fenwick’s Fifth Annual Digital Health Investor Summit

Fenwick’s fifth annual Digital Health Investor Summit brought together investors who are active in the digital health space to discuss the evolving digital health sector and their investment outlook for the year...more

OCR New Guidance Aims to Help Medical Mobile App Developers Predict when HIPAA Obligations Might Apply

Predicting whether the activities of a mobile health application developer trigger legal obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) presents some new challenges – not surprising...more

Infrastructure Deals Dominate Digital Health Investment in 2015

Among its list of defining quotes of 2015, Rock Health included one from a physician who was frustrated with the fact that, as she put it, “In my hospital there are 19 software systems across departments – few of which...more

Digital health funding hits $4.3 billion in 2015

A new report from Rock Health states that digital health funding in 2015 reached $4.3 billion from 180 merger and acquisition deals in the past year, primarily with IPOs in the first half of 2015. This represents 7 percent of...more

Infrastructure Investments Rule in Q3

Our analysis of digital health investment in the third quarter of 2015 revealed that just under $3 billion was invested in the sector and more than half of that went to infrastructure providers....more

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