Searching Content indexed under Technology by McDermott Will & Emery ordered by Published Date Descending.
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To Market, To Market: FDA's Digital Health Precertification Program
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive
United States
24 Sep 2019
Telemedicine Collaborations And Partnerships: Key Considerations For Success
Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare...
United States
2 Sep 2019
Reviewing Key Principles From FDA's Artificial Intelligence White Paper
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning
United States
29 Aug 2019
Dash To Digital Health? How The Regulatory Sprint To Coordinated Care Could Expand Access To Care
Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers' ability to fully leverage remote patient monitoring
United States
29 Jul 2019
FDA's Breakthrough Device Program: Opportunities And Challenges For Device Developers
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program
United States
26 Jul 2019
Three Tips For Tackling Risk In Digital Health
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance
United States
22 Jul 2019
4 Ways To Manage Retirement Plan Data In New Era Of Cybersecurity
IBM estimated last year that data breaches cost companies $148 per stolen record. Given that, not surprisingly, many employers have grown increasingly
United States
17 Jul 2019
CMS Innovation Center Proposes Telehealth Solutions In ET3 Model
As part of its efforts to provide patient-centered care and reduce costs for Medicare beneficiaries, the Centers for Medicare and Medicaid
United States
9 Jul 2019
Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies
The federal government has offered substantial incentives to providers to adopt and use certified electronic health record (EHR) technology.
United States
28 May 2019
DOJ's Enforcement Activity Against Individuals: Acute Focus On Telemedicine
DOJ's focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent
United States
22 May 2019
Patenting Your Digital Health Tech: When, Why And How
The digital health market is expected to grow beyond $379 billion by 2024, with a 27.7 percent compounded annual growth rate over the coming years.
United States
10 May 2019
Digital Health Drives Forward – A Roadmap Of Regulations
New digital health regulations arose at the federal and state level in 2018, bolstering the existing legal framework to further support and encourage digital health adoption in the context of care coordination and the move to value-based payment.
United States
21 Feb 2019
ERISA Class-Action Litigation Over Fees In Health And Welfare Plans
Sponsors and fiduciaries of health and welfare plans should be aware of a recently filed class-action lawsuit against alleged fiduciaries of a health plan.
United States
14 Dec 2018
Expanded Telemedicine Services Presented As Means To Address Opioid Crisis In New Legislation
Last week, President Trump signed the SUPPORT for Patients and Communities Act (SUPPORT Act).
United States
13 Nov 2018
The RUSH Act – Another Advancement In Telehealth Acceptance?
As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program.
United States
6 Nov 2018
Internal Revenue Service Outlines Critical Cybersecurity Safeguards To Protect Sensitive Data
The Internal Revenue Service and the Security Summit partners recently issued a news release outlining the "Security Six," ...
United States
17 Oct 2018
Digital Token Offerings And Sales Under Regulation S
Since the inception of Bitcoin in 2009, certain digital tokens (often referred to as cryptocurrencies) have been popularized as secure, decentralized and private alternatives to government-controlled currencies.
6 Sep 2018
SEC Director Makes Groundbreaking Speech About Blockchain Token Sales
The Director of the SEC's Division of Corporation Finance William Hinman gave a speech in which he discussed whether a digital asset ...
United States
17 Jul 2018
Blazing New Trails In Health Care And Technology Innovation Ventures
A proactive strategy for managing regulatory risk will help to avoid creating or discovering impediments that can disrupt or fatally derail the investment and at the same time enhance the digital health innovation's potential.
United States
20 Jun 2018
Recycle, Recycle, Recycle: Key Considerations For Research, Medical Education, And Other Secondary Uses Of Data
The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential ...
United States
7 Jun 2018
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