Better cybersecurity safeguards urged for medical devices, EHRs

A congressional panel issued a request for information on how to improve cybersecurity in the medical device sector, amid concerns that older “legacy” technologies may be more vulnerable to security threats than their modern counterparts.

By Susan Kelly • July 10, 2018

Healthcare startups raise $15B across 779 deals in first half of year

June was a slow month, however, with investments down 3% from the prior year, according to a Pitchbook analysis for Forbes.

By Meg Bryant • July 10, 2018

FDA pledges 'efficient regulation' of mobile health apps

The agency hopes to launch its software precertification program next year.

By Meg Bryant • July 5, 2018

Digital health funding sets new H1 record with $3.4B across 193 deals

The sustained growth reflects the sector’s maturation along with a healthy venture ecosystem, a new Rock Health report says. However, despite bullish investment in digital health startup, exits have been slow. 

By Meg Bryant • July 3, 2018

GE to spin off healthcare unit in latest restructuring

Moody's and investors applauded the move, which comes amid a reboot of the health division.

By Meg Bryant • June 27, 2018

FDA unveils software Pre-Cert update

The agency hopes to finalize the working model by the end of the year and launch a large-scale pilot program in 2019.

By Meg Bryant • June 21, 2018

Amazon reportedly forms Alexa health team

Smart speakers hold promise in the healthcare field, as they are increasingly being used to help specific populations like seniors and people with disabilities.

By David Lim • May 11, 2018

Fitbit, Google join to push patient-generated data into health records

The companies said they want to help physicians and patients better manage chronic conditions by combining Google Cloud's Healthcare API with Fitbit's Twine Health platform.

By David Lim • May 1, 2018

FDA lays out next steps for Pre Cert pilot

Nine companies are taking part, including Apple, Fitbit and Johnson & Johnson. The program aims to reduce certification checkpoints for software companies for low-risk software-based medical devices.

By David Lim • April 27, 2018

Hospitals must improve medication adherence system use to protect patients, report says

Many hospitals are struggling to properly use technology designed to prevent bedside medication errors.

By David Lim • April 13, 2018

HIMSS18: Eric Schmidt says future of healthcare lies in 'killer apps'

The former Google executive chairman gave a standing-room only crowd at the annual health IT convention in Las Vegas his predictions on the future of the space.

By Jeff Byers , Kim Dixon • March 6, 2018

Industry blasts FDA Clinical Decision Software draft

A group that includes software providers, medical device makers and drugmakers says that if implemented, the draft guide would "force many sellers of existing CDS software to remove their products from the market."

By David Lim • Feb. 7, 2018

FDA lays out digital health goals in 2018 strategic roadmap

The agency will continue to build out its Pre-Certification Pilot Program to help encourage the development of digital health tools.

By David Lim • Jan. 12, 2018

Blockbuster digital health funding to spill to 2018

"There will be an effort to look more closely at the impact on health outcomes and cost savings and not just 'is this a cool idea?'" says Chilmark Research's Brian Eastwood.

By Jeff Byers , Meg Bryant , Shannon Muchmore • Jan. 4, 2018

Latest MACRA, doctor fee rules could bring boost to telehealth, wearables

“This is a big step forward for Medicare’s ability to deal with chronic conditions," American Telemedicine Association's Gary Capistrant says of an unbundled payment code for remote patient monitoring.

By Meg Bryant • Dec. 14, 2017

FDA debuts new clinical support software draft guide, backs off certain regulations

The agency also issued a plan clarifying the regulation of certain digital health products such as mobile applications and finalized guidance on Software as a Medical Device.

By David Lim • Dec. 8, 2017

New alliance aims to advance digital therapeutics

Founding members include Akili Interactive, Propeller Health, Voluntis and WellDoc.

By Meg Bryant • Oct. 27, 2017

Digital health funding hits annual high of $4.7B at end of Q3

The sector continues to shift to a business-to-business strategy.

By Meg Bryant • Oct. 3, 2017

FDA unveils digital health pilot program to speed up certification process

The agency also published its Digital Health Innovation Action Plan, which provides detail and timelines related to digital health and the 21st Century Cures Act.

By Jeff Byers • July 27, 2017