On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more
The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm's chief client corporate development officer, who has broad management experience in the life sciences sector; a piece...more
USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies -
On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more
1/7/2020
/ Biologics ,
Collaboration ,
Digital Health ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovation ,
Investors ,
Japan ,
Life Sciences ,
Medical Devices ,
Startups ,
Venture Capital
Beware of “Most Favored Nations” Clauses in Commercial Contracts -
Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more
11/20/2019
/ Antitrust Violations ,
Competition ,
Contract Negotiations ,
Cybersecurity ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medical Devices ,
Most-Favored Nations ,
Patient Privacy Rights ,
PHI ,
Preferred Hospital Networks Arrangement
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products -
The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
6/24/2019
/ Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Privacy Rule ,
Life Sciences ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Popular ,
Pre-Market Notification ,
Regulatory Oversight ,
Regulatory Standards
On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) released an updated version of its "Code of Ethics on Interactions with U.S. Health Care Professionals" (HCPs) (the Code), which will take effect on...more
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 2) -
In Part 1 of this article from our last Digital Health Report, we looked at the opportunities and some of the potential limitations of...more
10/31/2018
/ Business Model ,
Digital Health ,
Early Stage Companies ,
Entrepreneurs ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Partnerships ,
Patent-Eligible Subject Matter ,
Patents ,
Startups ,
Strategic Planning ,
Technology Sector
Over the counter (OTC) drugs are medicines sold directly to consumers without a prescription from a healthcare professional. Traditionally, the range of OTC drugs has been limited to medical diseases and conditions for which...more
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) -
Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more
6/1/2018
/ Colleges ,
Digital Health ,
Due Diligence ,
Health Care Providers ,
Intellectual Property Protection ,
IP License ,
Joint Venture ,
Medical Devices ,
Partnerships ,
Software Developers ,
Technology Sector ,
Universities ,
Venture Capital
Machine Learning and Digital Health Applications -
The use of artificial intelligence (AI) algorithms to solve complex problems has risen dramatically in the last several years. In 2017, Gartner identified more than 1,000...more
3/9/2018
/ Digital Health ,
Health Care Providers ,
Innovative Technology ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Data ,
PHI ,
Section 101
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
12/22/2017
/ Apple Watch ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Medicare ,
Mobile Apps ,
Telemedicine
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
11/9/2017
/ 21st Century Cures Act ,
Acquisitions ,
Digital Health ,
Emerging Growth Companies ,
Emerging Technology Companies ,
Health Care Providers ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Software ,
Trade Secrets ,
Warranties ,
Wearable Technology
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
Consumer Digital Health: Market Shift Is Leading to New Opportunities -
The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more
In this issue:
- A New Accelerator Takes Digital Health Start-Ups to the Next Level
- The Return of the MedTech IPO Market
- Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters
-...more