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.
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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.
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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
14 tips to help your company implement wearables in wellness programs
Fitbit, Garmin, and Mio are just a few of the companies offering everyone the chance to keep track of their fitness level throughout the day. Features include tracking steps, sleep and workouts.
Companies, like Target, are finding ways to implement wearable technology into their Wellness Programs. The programs, a part of employee benefits packages, can help lower healthcare costs, reduce absenteeism and increase productivity.
Implementing the wearable technology is a viable option, but without proper implementation it could create legal challenges.
Experts from various industries came together at Fitbit's recent Captivate 2015 conference and created a list of best practices and lessons learned from their experiences with wellness programs tied to wearables.
James Martin with CIO.com compiled a list of the best tips from those speakers in San Francisco.
Employee wellness plans, privacy and compliance
1) Show employees their personal information is secure
Several speakers emphasized that organizations should show (not tell) employees that health and fitness data is secure.
Some employees initially hesitate to share step counts or other health data with their employers, according to Jim Huffman, senior vice president and head of U.S. Health and Wellness Benefits for Bank of America. These people worry that the information could negatively affect their insurance premiums, chances for promotions or opportunities for raises.
Bank of America is "loud and clear" when it regularly addresses such fears in employee communications and assures staff such information won't be used against them. Buffman said companies have to "prove it," too. In the second year of its wellness program, for example, Bank of America didn't increase health insurance premium rates for any of its U.S. employees, even though the company's own costs rose. Bank of America leaders felt it was important to "pay it forward" and demonstrate to employees that participating in its fitness programs is only beneficial. However, Huffman adds that organizations will "always have a portion of employees who will not share their information."
2) Go above and beyond to protect employee data
Wellness and fitness program managers should "take extraordinary steps" to protect sensitive information collected via wellness programs, Huffman said. He also suggested that companies work closely with HR managers to assure staff that their wellness program teams don't have access to sensitive data, such as employee health insurance claims.
Eric Dreiband, a partner with law firm Jones Day, stressed the importance of maintaining a secure "firewall" between data collected by wearable technology and personnel records. The goal is to keep staff health and fitness data away from supervisors or other decision makers, so that it cannot inadvertently affect employee pay or promotions.
If that data isn't kept separate, and there's an employee complaint, the government could investigate and file a lawsuit, according to Dreiband. The Equal Employment Opportunity Commission sued companies in the past because their wellness programs allegedly violated federal anti-discrimination laws when they coerced people to participate.
3) Stay up to data on relevant regulations
Organizations that use wearables to collect employee data need to be clear on the potential compliance and legal issues related to the Affordable Care Act (ACA), Health Insurance Portability and Accountability Act (HIPAA), and Americans with Disabilities Act (ADA), Dreiband said. Wellness plans that collect medical information, such as heart rate and blood pressure, must be voluntary and may not carry a penalty for non-participation in any way, or they could violate the ADA, for example.
Putting employee fitness data to work
4) Compare anonymous fitness data and business goals
Whenever possible, it's a good idea to tie aggregated, anonymous data from corporate wellness program or fitness challenges to metrics that measure business goals, according to Liz Boehm, experience innovation network director for Vocera, a healthcare communication system vendor.
By combining these data sets, senior management can see how (or if) wellness program engagement helps the company achieve fewer manufacturing errors, lower employee turnover rates, or achieve other business goals. These insights can help keep senior executives bullish on the company's wellness and fitness programs, and convince skeptics the programs are worth the effort and expense.
5) Don't overthink baselines
Companies should avoid getting bogged down when they try to determine baselines for the wellness and fitness program data they want to measure, according to Jennifer Benz, CEO of Benz Communications, which specializes in helping organizations communicate health and wellness programs to employees. (Notable Benz clients include Intuit and Adobe.)
"There's already a lot of great baseline data out there, so you don't have to figure out precisely where your organization is to figure out how to measure improvements."
6) Keep it simple
Companies shouldn't get carried away and try to measure too many things, Benz said.
"Most successful organizations find a couple of metrics to track that are key to their overall business environment," she said.
Wellness programs can often have a "halo effect," as well, giving employees a better sense of their health, according to Benz, which is "something you may not be able to measure, but will be able to see and hear among people in your organization."
Tips for enhanced communication, outreach for fitness programs
7) No silver bullet
There is no single communications channel that's best for raising employee awareness and engagement, according to Benz. So, it's best to embrace multiple channels and formats. Most employees have preferred ways of receiving information, such as viewing online video or reading infographics and email, and the way to reach the largest audience is by using more communication methods.
Ultimately, the goal is "to change wellness behavior, not communications behavior," Boehm said.
Bank of America uses "every form of communications possible" to detail updates, features and benefits related to its wellness program and health challenges, according to Huffman, including the company Intranet, email, "snail mail" sent to employee homes, and team meetings. Before opening each day, Bank of America branches also have "team huddles," which are ideal for communicating information about company wellness programs.
8) Share employees' positive experiences
Several speakers at the San Francisco Fitbit conference said sharing testimonials is an excellent way to engage employees in wellness programs or fitness challenges.
"People love to read stories about their colleagues," Benz said. For example, an 'average Joe' who was a smoker for 20 years successfully completed a cessation program offered by one of Benz's corporate clients. The company highlighted 'Joe's' accomplishment in one of its employee newsletters, and nearly 100 fellow employees emailed him to say the story inspired them to join the program, Benz said. Joe also told his company benefits manager that, after all the recognition he received for quitting, he "definitely can't start smoking again."
Boehm added that organizations should find testimonials from all levels of the company and "keep putting them out there." Employees featured in testimonials can be a wellness program's "best advocates."
9) Focus over generality in communications
Unfortunately, there's no one-size-fits-all approach to effective communication, Boehm said. "The more tailored your communications are (to individual interests), the more engagement you'll get." You're trying to get people to change their behavior, she said. But if your approach is too broad or general, employees might think the message doesn't apply to them.
10) Be timely and proactive
Organizations' communications should be timely and relevant whenever possible, according to Benz. She suggests following the "TaskRabbit model" by striving to make communications "helpful for others" and giving employees information they can act on. For example, if an employee needs an MRI, a company might provide information on affordable facilities that perform the test before the employee makes an appointment.
More tips for successful corporate wellness programs
11) It's not all about the Benjamins
It's never a good idea to depend solely on financial incentives to motivate employees. Many employers choose to increase financial incentives to motivate staff health improvement, but the majority of workers don't take full advantage of the incentives, according LuAnn Heinen, vice president, National Business Group on Health (NBGH).
In 2015, 79 percent of employers will offer monetary health incentives, up from 63 percent five years earlier, according to a 2015 NBGH and Fidelity Investments survey, which Heinen cited. The same survey also found the average maximum incentive amount rose to $693 this year compared to $594 in 2014, while only 47 percent of employees earn the full incentive amount, and 26 percent earn just a portion of the total.
Though important, financial incentives, as well as future health rewards don't always motivate sustainable participation in wellness challenges and fitness programs, Heinen said. The promise of fun, overall better quality of life, and higher energy levels are often more effective motivators, she said.
12) Help employees help themselves
Creativity can go a long way toward giving employees easy options to care for themselves. For example, mindfulness — the act of "being in the moment" —is gaining popularity in corporate wellness programs, according to Heinen. Pitney Bowes, for example, offers five-minute guided meditation for employees over the phone.
13) More physical activity isn't always better
The goal of increasing physical activity isn't always appropriate for all workers. Some workers, such as nurses or employees in packing and shipping departments are always on their feet, so increasing steps isn't necessarily a wise move, Boehm said. Instead, decreasing steps can make these types or workers more efficient in their jobs and "give them energy to focus on what matters most" at work and at home.
14) Cheaters never prosper
Organization shouldn't worry about fitness challenge "cheaters," or people who manipulate their fitness data. Companies that roll out a Fitbit Wellness program can enable or disable employees from manually logging steps, according to Amy McDonough, vice president and general manager, Fitbit Wellness. However, McDonough says Fitbit has "found that with good communications and transparency about how a program ties to incentives and what data is being shared, the majority of employees will be honest and will keep each other honest."
A way to take your wellness program beyond paper
Target is taking its wellness program a step further and giving its more than 300,000 employees access to a FitBit tracker. And to sweeten the deal, all employees participating in the FitBit Wellness Program will have a chance to earn money for the charity of their choice.
Employees can sign up to get the FitBit Zip ($59.95) for free or pay the difference for a more advanced FitBit.
Amy McDonough, vice president and general manager of Fitbit's wellness unit, told eWEEK that the deal with Target is one of the largest company-wide wellness arrangements it has made so far.
"The Target announcement was exciting because they are a strategic retail partner for Fitbit products and also a large employer," McDonough said. "It's a great example of how these larger organizations are really putting wellness at the forefront."
Employees who take advantage of the FitBit offer will be grouped into teams for a monthlong challenge. The winning team will get $1 million to funnel into a charity of their choice, Chief Human Resources Officer Jodee Kozlak told CBS News.
Kozlak added that employees will also receive extra discounts on fruits and vegetables, and healthy grab and go snacks will be featured near cash registers.
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