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Searching Content indexed under Healthcare by McDermott Will & Emery ordered by Published Date Descending.
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1
Is Your Software A Medical Device? FDA Issues Six Digital Health Guidance Documents
The FDA recently released six guidance documents as part of the agency's continued focus on updating the regulatory stance on software as a medical device and other digital health products
United States
16 Oct 2019
2
Third Circuit Perpetuates Tuomey's Controversial Stark Law "Volume Or Value" Standard
In U.S. ex rel. J. William Bookwalter, III, M.D. et al. v. UPMC et al., the US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law's...
United States
11 Oct 2019
3
New Podcast: Whose Data Is It Anyway? Collaboration In Digital Health
The demand for healthcare innovation is driving collaboration between formerly disparate healthcare companies and bringing in new players, ...
United States
4 Oct 2019
4
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
5
Vetting Relationships For Telemedicine Collaborations
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology
United States
20 Sep 2019
6
Court Dismisses Challenge To TTB's Rejection Of Health Claims On Vodka
In August, the US District Court for the District of Columbia issued its final decision in Bellion Spirits, LLC v. United States, Civ. No. 17-2538 (JEB).
United States
9 Sep 2019
7
Transgender Health Benefits: Best Practices And Legal Considerations
A growing number of medical organizations, courts and administrative bodies have stated that transition-related medical care is medically necessary and should be covered by employer-sponsored medical plans.
United States
4 Sep 2019
8
Healthcare Enforcement Quarterly Roundup | Q2 2019
In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape
United States
3 Sep 2019
9
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
10
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
11
DOJ Continues Telemedicine Enforcement In Q2 2019
During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine.
United States
29 Aug 2019
12
Genetic Testing Kits And FSAs
The IRS issued a private letter ruling (PLR) this week indicating that an FSA (and presumably an HSA and HRA) may reimburse a portion of the purchase of genetic testing and reports regarding ancestry
United States
28 Aug 2019
13
A New Day For The HRA
The Departments of Labor, Treasury, and Health and Human Services have released final rules removing the prohibition on pairing HRAs with individual health policies.
United States
2 Aug 2019
14
IRS Expands Scope Of Preventive Care Under Health Savings Account Rules
A new IRS notice will allow many with chronic health conditions who participate in high-deductible health plans (HDHPs) with health savings accounts (HSAs)
United States
31 Jul 2019
15
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
16
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
17
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
18
SCOTUS Refuses To Review Ninth Circuit Ruling On ACA Birth Control Rules
The US Supreme Court declined to review a recent Ninth Circuit decision, blocking the interim rules that exempted employers with religious or moral objections from providing birth control
United States
19 Jul 2019
19
Implications Of The Supreme Court's Tennessee Retailers Decision
As virtually everyone in the US alcohol beverage industry knows, last week the US Supreme Court handed down its opinion in Tennessee Wine and Spirits Retailers Assn
United States
16 Jul 2019
20
Digital Health In The UK: The New Regulatory Environment Under The Medical Device Regulation
Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years.
UK
16 Jul 2019
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