Bettering Health Plan Management Through Modern Healthcare Technology

Taking advantage of modern technology is part of the reason why Hierl excels in providing the best results for our clients. In this installment of CenterStage, we asked our Executive Vice President, Scott Smeaton, to give an in-depth overview of how we use our technological resources to create customized, high-quality, low-cost health plans for our clients.

Technology and Data

There are three steps to developing plans for our clients, when using technology and data. The first step is to identify the client’s cost drivers within their health program(s). For example, we may look at a client’s claims data and find their highest dollar claims are musculoskeletal – such as hip and knee replacements – identifying whether health plan members are going to the higher cost, lower quality provider. These are becoming much more prevalent and are among most plans top cost drivers. With the technology at Hierl, we can import our client’s data – medical and prescription claims and health screening results from wellness – and aggregate it into one technology platform. Doing so, will help keep our clients’ members updated on physician requests and advice.

Competitive Advantage

The second step beyond identifying our client’s cost drivers is to implement management programs and plan designs to address their health plan issues. This kind of technology is newer to the healthcare industry. It can be a great resource and tool that larger employers can use to their advantage. Think about Netflix. They analyze their viewer’s behaviors and apply predictive modeling in a way that they know what their viewers like to watch and when they want to watch it, incorporating those preferences into the ads their customers see. That kind of technology is coming to healthcare, allowing us to look at all claims and behaviors and predict where the next large claim will come from. This helps plan administrators fully understand what’s driving their health plan costs and do something about it through plan design changes, provider relations and contracting, member incentives, and member education and engagement.

Employee Betterment

After identifying areas that can be improved upon and creating a plan to address these cost drivers as discussed above, our third and final step is to create a communication program that will engage and educate employees. Our goal is to help employees understand that, within a healthcare system, there are some providers who perform better than others and cost less. When we give employees the tools and resources they need to be better healthcare consumers, everyone wins. Employer sponsored health plans have lower overall costs. This means their employees and their families lower their out-of-pocket costs, save healthcare dollars for the future, and have better outcomes. Not to mention that a happier, healthier employee is also a more productive employee at work and in the community. Hierl accomplishes this with our “Why Matters” program, which is a custom designed, year-round member education and communication program using a variety of mediums to reach our clients’ members. Through Why Matters, Hierl builds a custom (intranet) and mobile app for our clients to access basic information about their benefits 24/7. Think of it as a homepage to one of your favorite websites that you bookmark in your browser. This is where your members go to research, make decisions, educate themselves on your benefit offerings and how to be a better healthcare consumer. Based on the cost drivers identified through the process above we build out a 12-month calendar of communication materials specifically addressing the areas we’ve identified as a concern and can be delivered via paper, email, mobile app, etc.

Hierl strives to bring our clients the best possible solutions that result in high-quality, low-cost benefits. If you think your company needs to take this step toward improvement, please contact Scott Smeaton at 920.921.5921 or send him an email at ssmeaton@hierl.com.


Algorithmic Bias – What is the Role of HR?

How should HR professionals deal with the forthcoming algorithmic bias issue? Find out in this article.


Merriam-Webster defines ‘algorithm’ as step-by-step procedure for solving a problem…In an analog world, ask anyone to jot down a step-by-step procedure to solve a problem – and it will be subject to bias, perspective, tacit knowledge, and a diverse viewpoint. Computer algorithms, coded by humans, will obviously contain similar biases.

The challenge before us is that with Moore’s Law, cloud computing, big data, and machine learning, these algorithms are evolving, increasing in complexity, and these algorithmic biases are more difficult to detect – “the idea that artificially intelligent software…often turns out to perpetuate social bias.”

Algorithmic bias is shaping up to be a major societal issue at a critical moment in the evolution of machine learning and AI. If the bias lurking inside the algorithms that make ever-more-important decisions goes unrecognized and unchecked, it could have serious negative consequences, especially for poorer communities and minorities.”What is the role of HR in reviewing these rules? What is the role of HR in reviewing algorithms and code? What questions to ask?

In December 2017, New York City passed a bill to address algorithmic discrimination.Some interesting text of the bill, “a procedure for addressing instances in which a person is harmed by an agency automated decision system if any such system is found to disproportionately impact persons;” and “making information publicly available that, for each agency automated decision system, will allow the public to meaningfully assess how such system functions and is used by the city, including making technical information about such system publicly available where appropriate;”

Big data, AI, and machine learning will put a new forward thinking ethical burden on the creators of this technology, and on the HR professionals that support them. Other examples include Google Photos incorrect labeling or Nikon’s facial detection. While none of these are intentional or malicious, they can be offensive, and the ethical standards need to be vetted and reviewed. This is a new area for HR professionals, and it’s not easy.

As Nicholas Diakopoulos suggests, “We’re now operating in a world where automated algorithms make impactful decisions that can and do amplify the power of business and government. As algorithms come to regulate society and perhaps even implement law directly, we should proceed with caution and think carefully about how we choose to regulate them back.”

The ethical landscape for HR professionals is changing rapidly.

Read more.

Source:

Smith R. (15 February 2018). "Algorithmic Bias – What is the Role of HR?" [Web Blog Post]. Retrieved from address https://blog.shrm.org/blog/algorithmic-bias-what-is-the-role-of-hr

Employers using fast-feedback apps to measure worker satisfaction, engagement

In this article from Employee Benefit Advisors, we take a look at measuring worker satisfaction and engagement through the use of feedback applications. Let us know what your verdict is!


The days of employers conducting employee engagement surveys once every year might be coming to an end.

Thanks to “fast feedback” applications, employers can conduct quick online surveys of their employees to measure how engaged they are at their jobs. The data from these polls is then collated and presented, often in real time on dashboards, to employers to show their workforce’s level of engagement and satisfaction. Some of these web-based programs also can present CEOs with steps they can take to improve their environment and culture.

These tools are available from Culture Amp, Glint, TINYpulse, PeakOn and others.

One of the main benefits of fast feedback, according to Glint CEO Jim Barnett, is that it cuts down on “regrettable attrition,” which occurs when talented employees leave for better jobs.

Glint customers include eBay, Glassdoor, Intuit, LinkedIn and Sky Broadcasting. These clients send out e-mail invitations to workers and ask them to take a voluntary survey, which can feature either stock employee engagement questions or queries that can be fine-tuned for a specific workplace.

Glint recommends 10 to 20 questions per Pulse — what it calls employee engagement survey sessions — and results are sent back to the employer’s HR directors and senior executives. According to Barnett, the Pulses are confidential but not anonymous. Barnett explains that while anonymous surveys do not record the respondent’s name and job title, a confidential survey means that only Glint knows who took the Pulse. The employer is only presented data from specific job groups or job descriptors within an enterprise, such as a production team or IT support.

This month, Glint announced two new capabilities to its real-time employee feedback program, called Always-On and On-Demand Surveys. Always-On allows workers to express their concerns at any time and On-Demand Surveys gives managers and executives the opportunity to perform quick, ad hoc surveys of staffers.

“Some of our companies use the Always-On Survey if they want people on their team to give feedback at any time on a particular topic,” he says.

Firms also use fast feedback for onboarding new hires, Barnett says. Companies have set up Glint’s program to gauge new workers at their 30 and 60 day-mark of their employment to “see how that onboarding experience impacted their engagement,” he says.

Culture Amp also provides fast feedback tools via a library of survey templates that cover a range of employee feedback topics including diversity and inclusion, manager effectiveness, wellness and exit interviews. Culture Amp’s clients include Aligned Leisure, Box, Etsy, McDonalds, Adobe and Yelp.

“We encourage customers to customize surveys to make the language more relevant, and to ensure every question reflects something the company is willing to act on,” says Culture Amp CEO Didier Elzinga.

Culture Amp presents its survey results to employers via a dashboard that displays the top drivers of employee engagement in real time. “Users can then drill down to understand more about each question, including how participants responded across a range of different demographic factors,” Elzinga says.

Sometimes CEOs are presented with news they were not prepared to hear, according to Elzinga. Some customers take to the employee survey process with the mindset of ‘myth busting,’ he says. “They want to know if some truth they hold dear is actually just a story they’ve been telling themselves. Every now and then, an employee survey will provide surprising results to an HR or executive team,” he says. “Whether people go into a survey looking to bust myths or gather baseline data, the important part is being open to accepting the results.”

Glassdoor takes the pulse of its workforce

Glint customer Glassdoor, the online job recruitment site that also allows visitors to anonymously rate their current employer’s work environment, compensation and culture, not only urges its employees to rate the firm using its own tools, the company also uses Glint’s software to view employee engagement at a more granular level.

Glassdoor conducted its first Glint Pulse in October 2016 and has rolled out three since then. The next is scheduled for January 2018, according to Marca Clarke, director of learning and organizational development at Glassdoor.

“We looked at employee engagement and the things that drive discretionary effort [among employees who work harder],” Clarke says. “This is strongly correlated with retention as well.”

Clarke said that one Glint Pulse found that the employees’ view of Glassdoor culture varied from location to location. Of its 700-person workforce, people working in the newer satellite offices were happier than the employees in its Mill Valley, Calif., headquarters. She speculates that this response could be due to newer, more eager employees hired in brand new, recently opened offices.

“People think culture is monolithic that should be felt across the company but we could see that there was some variation from office to office. With Glint, we were able to slice the data not just by region and job function but [we could] go to the manager level to look at how people with different performance ratings think about the culture,” she says.

Recent research from Aon Hewitt found that a 5% increase in employee engagement is linked to a 3% lift in revenue a year later. According to Barnett, Glint clients that regularly conduct surveys and take steps to engage their employees often see a boost in the price of their company shares.

“Companies in the top quartile of Glint scores last year [saw] their stock outperform the other companies by 40%,” he says. “They now have the data and can see that employee engagement and the overall employee experience really do you have a dramatic impact on the result of their company.”

 

Read the original article.

Source:
Albinus P. (5 December 2017). "Employers using fast-feedback apps to measure worker satisfaction, engagement" [Web blog post]. Retrieved from address https://www.employeebenefitadviser.com/news/employers-using-fast-feedback-apps-to-measure-worker-satisfaction-engagement?brief=00000152-1443-d1cc-a5fa-7cfba3c60000


It’s the most stressful time of the year: 5 tips to get your employees through the holidays

It’s that time of year again. Employees are preoccupied with thoughts of holiday shopping, party planning and visiting relatives, and the stress of it all can seriously impact their work. So what can you do to help?

While stress is a year-round issue, there are more obvious triggers for it around the holidays. Mark Malis, the head of global human resources at LifeWorks, assembled a list of five common causes of stressduring this time of year, and what you can do to tackle them.

1. Heavier workloads

Employees taking more days off means less time to get things done. It’s hard not to feel overwhelmed with work and holiday deadlines coming up fast.

The fix: Help your employees relax a little by making them feel valued. Let them know their hard work isn’t going unnoticed. You can even encourage employees to identify which colleagues are going the extra mile, and reward them with gifts.

2. Unhealthy eating

Plenty of sugary food options are always floating around during the holidays. All of the cookies and eggnog can really make your employees feel sluggish.

Encourage your employees to make better choices by hosting a healthy potluck. You can even turn this initiative into a weight loss competition to keep the good food choices going.

3. Finances

With the average American shopper expecting to spend almost $1,000 this holiday season, it’s no wonder money is on everyone’s mind.

Financial wellness workshops or budget planning seminars could really help your employees come up with a realistic budget and control their holiday spending. The less they’re worrying about money, the more employees will be able to focus on their work.

4. Depression

The holidays aren’t a joyful time for everyone. Some employees could be struggling with sad memories that resurface around this time of year.

When it comes to mental health, openness is always a good way to go. Encourage employees to discuss these feelings with each other in a supportive group setting. This can allow employees to help each other find solutions and make anxious workers feel less alone.

5. Illnesses

With the holiday season comes cold and flu season, too. Getting sick when you have a million things to get done can be disastrous.

It’s important to remind your employees about good hygiene practices. Make it clear that anyone who’s sick needs to stay home; the last thing you need is half the office out with the flu. Distributing handbooks or posters with tips to stay healthy can be a big help, too.

 

You can read the original article here.

Source:
Mucha R. (16 November 2017). "It’s the most stressful time of the year: 5 tips to get your employees through the holidays" [Web blog post]. Retrieved from address http://www.hrmorning.com/its-the-most-stressful-time-of-the-year-5-tips-to-get-your-employees-through-the-holidays/


5 ways digital tools can help build a better benefits package

"...digital tools can be excellent motivators and are a popular option for keeping employees to their wellness objectives..." In this article from Employee Benefit Advisor, we get a fantastic look at some statistics and digital tools to create better employee engagement.


The American workforce has an employee engagement problem: Half of U.S. workers are disengaged, according to a recent Gallup poll. That not only has a detrimental effect on individual wellness, but on company culture and the bottom line. According to The Engagement Institute, disengaged employees cost organizations between $450 and $550 billion every year. In addition to being less productive, they’re also more likely to quit.

One of the most effective ways to improve employee engagement is to offer better benefits. In fact, research conducted by Willis Towers Watson found 75% of employees said they were more likely to stay with their employer because of their benefit program. This demonstrates the value of designing an employee benefits package that really works for your staff. And to even better engage workers with benefits, employers should utilize HR apps and employee wellness software.

They vary in functionality, device compatibility, and of course price, but they all share five considerable advantages:

They’re highly adaptable. Unlike programs that rely on in-person use or resources that are primarily stored in binders, digital content can be updated on the fly. This flexibility makes it very easy to keep the information current and relevant, and it even opens the door to personalized benefits. For instance, if each employee has their own login, they can bookmark the resources they find most useful and receive suggestions based on those picks. Seventy-two percent of employees in a MetLife survey say being able to customize their benefits would increase their loyalty to their current employer, which makes this perk doubly advantageous.

They’re fully integrative. One major complaint employees have is that their health information is so disjointed. Dental, physical, psychological and nutritional data is siloed, creating a cumbersome situation for employees when it comes to accessing and updating their records. Digital tools neatly solve this problem by collecting all these resources in one place. All employees have to do is sign into one account to view all their health-related resources, benefits, emergency phone numbers, enrolment information, health savings account balance and so on.

They’re constantly accessible. Have you noticed your staff using fewer and fewer benefits over time? It’s easy to assume they’ve lost interest, but chances are they’ve simply forgotten what’s available to them. Digital tools are a fantastic way of combating that attrition for a couple of reasons. First, they’re super easy to access because they can be used essentially anytime, anywhere. The second reason your staff is more likely to continue using their benefits with a digital platform is because it can serve them with notifications and reminders. They no longer have the excuse of being unaware when fresh content is added, or missing medical appointments.

They encourage employee goals. To add to the previous point, digital tools can be excellent motivators and are a popular option for keeping employees to their wellness objectives. Two of the most common goals are weight loss and smoking cessation, but your employees can use calendar, reminders, notes, fitness trackers and other features to push them toward any goal they like.

They’re easily scalable. Finally, digital tools are the most efficient way of reaching a large employee base, especially if they’re spread over a large geographical distance. It’s impossible to expect a thousand employees located in different states to attend a stress management seminar, for example, but it’s not unreasonable to ask them to watch a five minute video or listen to a podcast. Digital resources are changing the game when it comes to reaching all employees equally so that no one gets left behind.

Some things to keep in mind

Now that you’ve been convinced to digitize your employee wellness program, there are a couple of assurances you should make. The first is confidentiality. Your employees need to feel safe accessing your health resources, so guaranteeing the security and privacy of their information is a must. You should also make accommodations for various accessibility concerns. In other words, having all your resources in video format isn’t helpful for employees who are visually impaired. Also be aware of the different situations in which your staff might need access (at home, on the go, with or without an internet connection, etc) to ensure maximum ease of use.

Why is this all so important? As cool and cutting-edge as many of these digital tools are, at the end of the day your goal is to promote employee well-being and engagement. Anything that encourages your staff to come into work with a smile on their faces is worthwhile. Gallup studies have shown highly engaged organizations are 21% more profitable, 17% more productive, and achieve a 41% reduction in absenteeism. No matter how effective your current benefits package is, you can — and should — take it to the next level with a digital program.

 

Read the original article.

Source:
Mittag A. (17 November 2017). "5 ways digital tools can help build a better benefits package" [Web blog post]. Retrieved from address https://www.employeebenefitadviser.com/opinion/5-ways-digital-tools-can-help-build-a-better-benefits-package?feed=00000152-1387-d1cc-a5fa-7fffaf8f0000

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HRL - Man - Working - Laptop

Using data to identify high-intent consumers

Does your company struggle with acquiring high performing leads? Check out this article from Property Casualty 360 degrees written by JAIMIE PICKLES.

You can read the original article here.


For years, insurance companies and agents have acquired third-party internet leads as an efficient way to supplement their own lead generation efforts. But with the shift toward digital engagement and increasing regulatory compliance concerns, acquiring high performing leads has become a much more complicated venture.

According to a recent study by J.D. Power, 74% of auto insurance consumers use insurance brand or aggregators websites for obtaining quotes and information. This is something that holds true across almost all lines of insurance.

Regardless of device, the preferred platform for shopping is now digital.

But while brand websites generate a percentage of insurance leads, more consumers are choosing the choice model that internet lead generators and aggregators offer to research and obtain quotes. This is because more consumers prefer to have access to what they perceive as independent and unbiased sources for information and quotes.

 

Mitigate TCPA compliance risk

Compliance with the Telephone Consumer Protection Act (TCPA) has become more of a priority for insurance brands and their partners over the past few years. TCPA lawsuits filed by consumers are on the rise — growing by a factor of 1,273 percent since 2010 — and a number of large insurance brands have been part of multimillion-dollar TCPA settlements.

For example, in May 2017, a Florida-based insurer settled a class action TCPA lawsuit for $4.25 million. And that does not include the court costs and legal fees or the cost to counter bad the bad PR and lost brand reputation from the case.

Knowing definitively that a consumer has given consent to be contacted is a must. Ted Todd Insurance is a multi-office agency in Florida which generates leads on its own website and buys online leads from third party lead generators. They assure TCPA compliance by using a SaaS-based solution to track and verify consumer consent.

CEO Charley Todd says, "the technology tracks and assures the existence of the consumer’s consent, delivering a positive first experience for every new customer, and provides persuasive evidence in the event of a consumer complaint or lawsuit."

 

Analyze the right data

With the overabundance of data that insurance brands have, from internal and external sources, it is not always easy to make sense of it all. Even with a sophisticated data science and analytics program, the key is getting access to the right data at the right time, to help optimize your marketing programs.

In the case of customer acquisition, that begins with having access to data that you can  use to help score, prioritize and route higher-performing leads. By knowing the origin and history of your leads, you’ll be able to mitigate TCPA compliance risk and prioritize selection of and engagement with higher-intent consumers.

The majority of the top ten insurance companies in the United States are doing just that — connecting the dots and using sophisticated technology and data — to gain real-time intelligence into the origin, history and intent of the leads they are acquiring. Such solutions enable insurance companies and agents to follow consumers in real time on their buying journeys until the end when consumers purchase a policy, helping insurers observe and access behavioral data which they can use to analyze the intent of the consumer.

When marketers gain the ability to identify and take action on consumer behavioral data, buying low-intent leads is no longer part of the "cost of doing business" in lead management and analysis. Brands that leverage these insights gain efficiencies and can better focus their precious time and budgets on productive leads.

 

Optimize lead acquisition and marketing

In implementing technology solutions, here are five tips to supercharge your lead generation.

  1. Know the age of your leads. If you’re measuring speed-to-lead from the moment you received a lead post, you are missing a key data point. It’s not about when you received the lead, but rather when the consumer actually submitted the inquiry.
  1. Be proactive in avoiding fraudulent leads and those that are not TCPA compliant. Consumers who didn’t fill out the form or who filled it out six months ago have no intent to buy from you. Also, these leads put you at risk for TCPA complaints. Only purchase leads that are TCPA compliant. You don’t want to damage your brand and reputation, or take on the costs if you are sued by a consumer. You need a vendor who can help you identify, in real-time, that your leads are compliant and provide persuasive proof that a consumer gave consent to be contacted.
  1. Don’t get dupedMany marketers assume that a duplicate is the result of recycled data. They think that the same consumer means it is the same inquiry. In fact, it could very likely be the same consumer with a brand new inquiry, which is actually indicative of a high-intent consumer. Know the difference.
  1. Understand if leads are shared vs. exclusive. Know if your leads are being shared with some of your competitors. If they are, you need to determine how many other competitors that lead is being shared with and whether you are the first or last to receive it.
  1. Right price your leads. If you find a vendor who will help you identify low intent leads, you can reallocate that spend and pay more for higher intent leads. This is a key strategy to quickly and notably improve lead conversion.

 

You can read the original article here.

Source:

Pickles J. (9 October 2017). "Using data to identify high-intent consumers" [Web Blog Post]. Retrieved from address http://www.propertycasualty360.com/2017/10/09/using-data-to-identify-high-intent-consumers?ref=hp-news


Workout - Girl - Stretching - Pixabay

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 http://www.benefitspro.com/2017/09/27/apple-fitbit-to-join-fda-program-to-speed-health-t

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 http://www.benefitspro.com/2017/09/27/apple-fitbit-to-join-fda-program-to-speed-health-t