The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more
These are exciting times for the advancement of healthcare, whether you’re a hospital, health system, or healthcare technology company or a consumer that benefits from the proliferation of products and services provided. In...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more
4/14/2021
/ Artificial Intelligence ,
Data Protection ,
Digital Health ,
Exclusivity ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Software ,
Supervision and Collaboration Agreements
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
1/8/2021
/ Biden Administration ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Digital Health ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more
The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more
Blockchain continues its buzz in healthcare for its potential to revolutionize patient records, medical data, medical billing, and wearable device use. Healthcare stakeholders may consider using this technology to advance...more
With the passage on January 22 of continuing appropriations through February 8 (HR 195), the moratorium on the medical device excise tax has been further extended until January 1, 2020, providing relief to medical device...more
Agency also launches voluntary pilot program as first step in developing software pre-certification program....more
New legislation includes a broad regulatory exemption for medical software.
On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more
7/27/2015
/ Biotechnology ,
Digital Health ,
Electronic Medical Records ,
FCC ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Hospitals ,
Marketing ,
Medical Devices ,
Patient-Specific ,
Premarket Approval Applications ,
Software Developers ,
State Regulators ,
Sunshine Act ,
Telemedicine