News & Analysis as of

Digital Health

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

by McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

Health Update - November 2017

Fraud and Abuse 2017: Understanding Trends and Avoiding Actions - Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Digital Health: FDA Announces New Policy for Genetic Testing Regulation

by Holland & Knight LLP on

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk...more

Health Update - October 2017

A New Look at Digital Health Business Models - Editor’s Note: The Commonwealth Fund is developing an innovative digital health advisor (DHA)—an integrated suite of digital services that would provide consumers with health...more

Five Takeaways From Fenwick’s Sixth Annual Digital Health Investor Summit

Fenwick’s Sixth Annual Digital Health Investor Summit started on an upbeat note with Rock Health’s Megan Zweig sharing the venture fund’s mid-year funding report. After the uncertainty brought by the 2016 presidential...more

Digital Health Update: Tech and Health Care Giants Selected for FDA’s Pre-Cert Program

by Kelley Drye & Warren LLP on

In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry. Consistent with that, and furthering the...more

IP and healthcare in South East Asia: “Bigger than BRIC”. So why aren’t you filing your patent applications there?

by FPA Patent Attorneys on

The South East Asian healthcare market is emerging as one of great importance, expected to experience faster rates of healthcare spending growth over the next 5 years than the BRIC (Brazil, Russia, India, China) countries...more

Home Care: The Digital Health Opportunity

by McDermott Will & Emery on

A recent article in Kaiser Health News highlights the health risks associated with the increased effort to get patients home—namely, the need for families to gain and effectively deploy the skills needed to care for...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

A Dynamic Digital Health Sector Means More and Bigger Deals

The digital health sector is beginning to mature and investors are pouring more money into more deals, reports Rock Health in its survey of digital health investment in the first half of 2017. And, we might add, into bigger...more

Health Alert (Australia) 28 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland (QLD) 21 August 2017 - A Practitioner v The Health Ombudsman [2017] QCAT 265 - PROFESSIONS AND TRADES – HEALTH CARE...more

Manatt Digital - August 2017

Introduction - The Internet of Things is a critical topic of discussion and one of the areas that we expect will significantly contribute to the overall pace of innovation and change within the digital ecosystem in the...more

The FDA's new Digital Health Plan

by Thompson Coburn LLP on

The US Federal Food and Drug Administration (‘FDA’ or ‘Agency’) Commissioner Dr Scott Gottlieb has used an FDA blog post to announce plans for a new digital health devices initiative, specifically the initiative’s Digital...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs

by Arnall Golden Gregory LLP on

Scott Gottlieb, M.D., FDA's commissioner, recently announced new digital health initiatives that will aid in the agency's push to regulate and support digital healthcare in the medical device space. In a statement posted to...more

FDA’s Health Software PreCert program to fast-track innovation

by Thompson Coburn LLP on

Digital information has taken over our day-to-day lives, and the federal Food and Drug Administration (FDA) continues to recognize that this includes many aspects of our health care as well. This is clearly demonstrated by...more

FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act

by Morgan Lewis on

Agency also launches voluntary pilot program as first step in developing software pre-certification program....more

Health Care Market Intelligence Private Equity Summary Report - July 2017

by Benesch on

A Look Back at the First Half of 2017... At the midpoint of 2017, deal data suggests deal volume (both PE and M&A) continues to trend downward – a trend that started in 2016 – however, despite this, deal values are...more

FDA’s Software Pre-Cert Program: More Details Revealed

by Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

by McDermott Will & Emery on

August 1, 2017, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory...more

New FDA Digital Health Program

by Holland & Knight LLP on

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more

US Food and Drug Administration’s New Digital Health Innovation Action Plan Details a Software Precertification Pilot Program

by McDermott Will & Emery on

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more

FDA Announces New Digital Health Innovation Programs

by Ropes & Gray LLP on

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has announced new plans to streamline the development and availability of high...more

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