Digital Health

News & Analysis as of

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

AdvaMed 2015 Highlights – Part Two of Two

Another panel concerning digital health was entitled: “The Hidden Life of Devices: Cybersecurity and Embedded Medical Devices”. Debra Breummer, Manager, Clinical Information Security, Mayo Clinic, said that cyber security is...more

Investments in Digital Health Infrastructure Dominate in August

At our Digital Health Summit earlier this year, Malay Gandhi, Managing Director at Rock Health, noted that once digital health venture investing accounts for 10% of all venture investment, we should start breaking out...more

Get Your Questions Ready

A lot has changed since the HIPAA Privacy Rule was finalized in 2002 and the HIPAA Security Rule was finalized a year later in 2003. The iPhone had not been released (that happened in 2007), Apple had just released the...more

Alert: Key Regulatory Considerations for Digital Health Companies

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

[Webinar] The Digital Health Update: Recent Developments in the Regulation of Medical Devices and Health Apps - Sept. 22nd, 1:00...

Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Patent Strategies in the Digital Health Care Space

You are founding a startup with a great new idea to revolutionize a key health care segment, but you know the digital health space is packed with potential competitors. Your technology and first-mover advantage create...more

[Webinar] Digital Health Update: Focus on Health Tech Startups - June 23, 1:00 CDT

Health care startups are expected to attract billions in venture capital in the next few years. Despite the pace and excitement this surge of investment creates, these next-wave digital disruptors need to keep three legal...more

Jawbone and Oscar Lead Record Breaking Month for Digital Health Financings

Two blockbuster deals drove digital health financings to record levels in April. The month saw a total of nearly $790 million in deal flow, with the ten largest financing transactions of the month matching the first quarter...more

Investment in eHealth: 2014, and what the future holds

Digital health, a category that was virtually nonexistent five years ago, has exploded in recent years and shows the potential to remake the way healthcare is delivered worldwide. Rock Health, the digital health incubator,...more

Digital Health Investment Maintains Momentum in 2015

Digital health investment is off to a healthy start in 2015 with our friends at Rock Health reporting more than $630 million invested in the first quarter. Fenwick clients Augmedix and Centrillion Technology Holdings received...more

Alert: 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...more

Digital Health Enjoys Tremendous Growth in 2014

What a difference a year makes. Last year, we noted that 2013 was a blockbuster year for digital health investments with almost $2 billion of private capital going into the sector. We highlighted the 10 largest deals of 2013,...more

EU Art. 29 Working Party Letter on Health Data and Apps

The EU Article 29 Working Party (“WP29”) has published a letter to the European Commission (“EC”) on the scope of health data in relation to lifestyle and well-being apps, following the EC’s Working Document on mHealth and...more

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