Posts tagged Digital Health
OIG’s Call for Increased Oversight of Remote Patient Monitoring Misses the Mark

Learn about the Office of Inspector General’s new report around remote patient monitoring and the key areas where it misses the mark.

Read More
Point Solution Fatigue, Meet M&A: How Strategic Transactions Can Transform Digital Health

Explore how strategic mergers and acquisitions (M&A) can reduce or even eliminate point solution fatigue by creating more comprehensive and integrated platforms that will improve patient care and reduce administrative burden.

Read More
Digital Therapeutics Alliance Summit 2024: 5 Takeaways for DTx Innovators

The Digital Therapeutics Alliance Summit 2024, held in Washington, D.C., brought together over 500 industry leaders (including NGL’s own Carrie Nixon and Michael Schellhous), innovators, and key stakeholders to discuss the current state and future of digital therapeutics (DTx). 

Read More
FTC Finalizes Changes to Health Breach Notification Rule: What Digital Health Companies and App Developers Need to Know

The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule (HBNR), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.

Read More
How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

No centralized framework for the regulation of artificial intelligence in the United States currently exists. That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. Experienced entrepreneurs and executives know that the ability to peer into the future can pay dividends, and we agree.

Read More
[Webinar Replay] The Top 3 Privacy Concerns for Digital Health Innovators

Discover how Privacy compliance impacts Digital Health Startup founders and executives in terms of access to capital and securing key vendor agreements in this webinar replay. You may not have ever looked at Privacy this way before, and we encourage you to explore this perspective so you can close those critical deals without unnecessary delay.

Read More
Intellectual Property for Digital Health Companies: How a Multi-Faceted Strategy Balances Patentability Barriers

If you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.

Read More
4X growth in 5 years: Why investment in Mental and Behavioral Health is exploding

In honor of National Mental Health Month, we’re taking a look at how we’re using these apps in our business, what some of our mental and behavioral health clients are doing, three ways the market is growing and changing, and what’s driving this transformation. If you’re an investor, a digital health company, or a healthcare provider, then this conversation is especially relevant for you.


Read More
What is a Value-Based Enterprise? New Opportunities for Digital Health and Healthcare Innovation

Dramatic changes to the Anti-Kickback Statute and the Stark Physician Self-Referral Law regulations present an unprecedented opportunity for healthcare providers and digital health companies to create new business arrangements that align incentives around care coordination and patient engagement. Such arrangements are the foundation of the Value-Based Enterprise.

Read More
Discover how six important additions and amendments to the physician self-referral law ("Stark") could create opportunities to grow your healthcare business in 2021

A Final Rule published by CMS makes several important changes to the Stark Law that will be a boon for physicians eager to more closely coordinate with other providers to (1) better manage patient care and (2) to participate in the shift to value-based reimbursement.

Read More
Remote Patient Monitoring in the 2021 Medicare Physician Fee Schedule: The good, the bad, and the ugly

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released its Final Medicare Physician Fee Schedule for 2021 (the “Final 2021 MPFS”), revising payment policies for services provided to Medicare beneficiaries by medical practitioners. These policies will take effect on January 1, 2021. Read on for insights from Team NGL.

Read More
Changes to the Anti-Kickback Regulations are Good News for Digital Health Innovation and the Shift to Value-Based Care

The Office of the Inspector General for HHS released a Final Rule aimed at reducing regulatory barriers and facilitating the move towards value-based care and giving healthcare providers and digital health companies more flexibility to enter into new business arrangements. This article is a high-level overview of the Rule and what it may mean for the future of healthcare.

Read More
Reimbursement for Virtual Check-ins and e-Visits in the Proposed 2021 Medicare Physician Fee Schedule

On August 3, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released it Proposed Medicare Physician Fee Schedule for CY 2021 (“Proposed MPFS”), seeking to expand reimbursement for Virtual Check-ins and e-Visits as a way of improving access to patient care. CMS proposes seven new HCPCS codes for these “Communication Technology-Based Services” that could be billed by practitioners who cannot bill Evaluation and Management (“E/M”) services independently.

Read More
Op-ed by Carrie Nixon in The Hill: 5 Actions to Fuel the Digital Health Momentum

Nixon Law Group’s Managing Partner, Carrie Nixon, was quoted in an op-ed for The Hill discussing 5 actions to fuel the digital health momentum. "The COVID-19 public health emergency has forcefully opened the door for widespread adoption of telehealth, remote patient monitoring, and other digital health platforms by patients and providers alike."

Read More
Is Your Digital Health or Remote Patient Monitoring Company Violating the BIPA?

Historically, biometric data – think fingerprint scans to “clock in” and face recognition technology for identifying potential suspects – has been collected by employers, law enforcement, and financial institutions and used for security purposes. As technology evolves and becomes more sophisticated, private companies—including digital health, telemedicine, and RPM companies—are beginning to incorporate biometric data from consumers and patients into their solutions.

Read More