News & Analysis as of

Digital Health

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

Telehealth & EHR Meaningful Use Payments—Expect Greater Scrutiny in Upcoming Medicare Audits

by Jones Day on

In July 2017, the United States Department of Health and Human Services' Office of Inspector General ("OIG") revealed two new Work Plan items related to digital health: first, a review of Medicare incentive payments for...more

Health Update - July 2017

Contracting With Technology Vendors: Obligations and Compliance Strategies - Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more

AGs Weave Themselves Into Patchwork of Digital-Health Regs

by Pepper Hamilton LLP on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

2017 Digital Health Funding For Emerging Companies Setting Records

by Cozen O'Connor on

2017 is setting records for the funding of digital health emerging companies according to two recent reports. Two leading digital health stakeholders StartUp Health and Rock Health published separate reports in the last two...more

Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

by McDermott Will & Emery on

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the...more

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

100 Results
|
View per page
Page: of 4
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.