Apple, Fitbit to join FDA program to speed health tech
Wondering how technology can speed the process of developing health tech? In this article from BenefitsPro written by Anna Edney, gain a close insight on how Apple and Fitbit are working together with the FDA to make your health of vital importance.
You can read the original article here.
A federal agency that regulates apples wants to make regulations on Apple Inc. a little easier.
The Food and Drug Administration, which oversees new drugs, medical devices and much of the U.S. food supply, said Tuesday that it had selected nine major tech companies for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Scott Gottlieb said in a statement.
The program is meant to let the companies get products pre-cleared rather than going through the agency’s standard application and approval process that can take months. Along with Apple, Fitbit Inc., Samsung Electronics Co., Verily Life Sciences, Johnson & Johnson and Roche Holding AG will participate.
A new report and video from the Health Enhancement Research Organization (HERO) identifies six promising practices for effectively integrating wearables...
The FDA program is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that may be used by patients or their doctors to prevent, diagnose and treat conditions.
Apple is studying whether its watch can detect heart abnormalities. The process it will go through to make sure it’s using sound quality metrics and other measures won’t be as costly and time-consuming as when the government clears a new pacemaker, for example. Verily, the life sciences arm of Google parent Alphabet Inc., is working with Novartis AG to develop a contact lens that could continuously monitor the body’s blood sugar.
Faster Pace
“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” Gottlieb said in July when he announced that digital health manufacturers could apply for the pilot program.
Officially dubbed the Pre-Cert for Software Pilot, Gottlieb at the time called it “a new and pragmatic approach to digital health technology.”
The other companies included in the pilot are Pear Therapeutics Inc., Phosphorus Inc. and Tidepool.
The program is part of a broader move at the FDA, particularly since Gottlieb took over in May, to streamline regulation and get medical products to patients faster. The commissioner said last week the agency will clarify how drugmakers might use data from treatments already approved in some disease to gain approvals for more conditions. In July, he delayed oversight of electronic cigarettes while the agency decides what information it will need from makers of the products.
Rules Uncertainty
As Silicon Valley developers have pushed into health care, the industry has been at times uncertain about when it needed the FDA’s approval. In 2013, the consumer gene-testing company 23andMe Inc. was ordered by the agency to temporarily stop selling its health analysis product until it was cleared by regulators, for example.
Under the pilot, the FDA will scrutinize digital health companies’ software and will inspect their facilities to ensure they meet quality standards and can adequately track their products once they’re on the market. If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all.
More than 100 companies were interested in the pilot, according to the FDA. The agency plans to hold a public workshop on the program in January to help developers not in the pilot understand the process and four months of initial findings.
You can read the original article here.
Source:
Edeny A. (27 September 2017). "Apple, Fitbit to join FDA program to speed health tech" [Web Blog Post]. Retrieved from address https://www.benefitspro.com/2017/09/27/apple-fitbit-to-join-fda-program-to-speed-health-t
Healthy employees create competitive advantage
Originally posted September 24, 2013 by Emily Holbrook on https://www.lifehealthpro.com
It may come as no surprise to many that healthier employees are more productive employees, creating a competitive advantage for their employer. That's according to a recent study by Integrated Benefits Institute (IBI), a workforce health and productivity research and measurement organization.
The company studied 1,268 employees at 53 organizations and found that employees that work at companies with a strong commitment to a healthy workforce "spend more time working, work more carefully and concentrate better than employees at other organizations," according to the report.
“If a workplace sets a high priority on the health of employees — who, in turn, are healthier and have better job performance — then it can reasonably be said that an employer’s culture gives it a competitive advantage. Workplace culture reflects the priorities of company leadership and is an area where employers have some leverage to improve business performance,” stated IBI research director Kimberly Jinnett, PhD, the main author of the report.
The study also found:
- Not careful at work: Workers in an organization with a weak health culture reported not being careful at work “all” or “most of the time” more than three times more frequently than those who work in organizations with a strong health culture.
- Not working as often: 44 percent more employees who work in an organization with a weak health culture reported not working as often as they should have “all” or “most of the time” as compared with employees in organizations with a strong health culture.
- Not concentrating: 31 percent more employees who work in companies with a weak health culture reported they did not concentrate “all” or “most of the time,” compared with employees in organizations with a strong health culture.
- Getting less work done: There was no difference in the responses from those in a strong versus a weak health culture with regard to getting less work done — but employee health is a differentiating factor. Emotional distress and overall health strongly influence how much an employee accomplishes, and employees in organizations with a weak health culture have worse outcomes on both measures.
IBI President Dr. Thomas Parry said "as more employers recognize that health influences productivity, as well as health care costs, health outcomes such as absence, disability and presenteeism are being brought into the larger discussion of the business cost of poor health."
Of course, this is not the first time that research has shown the connection between poor employer health culture and employee ailments (and therefore, productivity) and it won't be the last. According to IBI, employers that wish to increase their focus on health-related job performance and its impact on the bottom line "should broaden their view from the individual health of employees to additional organizational factors, including health culture and employee well-being."
Companies are, albeit slowly, starting to see the link between employee well-being and productivity.
