Getting digital transformation in healthcare on the fast track

Outdated protocols, overextended workforces and hundreds of wasted hours in administrative tasks are just a few of the opportunities for a digital overhaul in the healthcare industry. There are tremendous opportunities for digital transformation in the healthcare industry. Read this blog post to learn more.


At first glance, the healthcare field seems to be a goldmine for digital innovation. An overextended workforce, outdated protocols, hundreds of wasted hours in administrative tasks, a patient population that is wide open to digital solutions, a multitude of inefficiencies and redundancies — the opportunities for digital overhaul in healthcare are myriad.

Yet every year the graveyard of digital health tools gets more crowded as innovators fail to overcome healthcare’s uniquely complex barriers to their adoption.

Goldmine and graveyard, the tremendous opportunities for digital transformation in healthcare and the seemingly insurmountable barriers to its adoption are two sides of a coin. They spring from the same root causes: the lack of financial incentives to implement digital solutions; the high stakes that necessitate a cautious approach; and most significantly, providers’ seeming unwillingness to abandon proven workflows or sunk costs to take a chance on a disruptive solution.

This last cause is often the greatest barrier to getting innovation through the door.

Clinicians are the primary end-users of digital health, and a clinical champion can make all the difference in whether a solution is adopted. But in the face of the physician shortage in the United States, doctors don’t have time to trade out their proven workflows to take a risk on a solution that may or may not be successful, and will almost certainly take time to learn and implement into their practice. The majority of providers are already at capacity — 80% have no time to see more patients or take on more duties. Thus what seems like an unwillingness to change is often an inability to find the time to change.

Many physicians agree that digital tools and solutions are worthwhile in theory, but with an average workload of 40-60 hours a week, they don’t have the space in their schedules to evaluate these solutions. As it is, the amount of patients that a physician sees in a day (the most rewarding part of their jobs, according to 80% of doctors) has been reduced in recent years to make time for the mountains of non-clinical paperwork and administrative duties that they are responsible for.

Because of their packed schedules, physicians often default to the status quo for sanity’s sake: 40% of physicians see up to 20 patients per day, with another 40% seeing more (anywhere from 21 to over 70); and all spend almost a quarter of their day on administrative duties like inputting data into EMRs. If physicians do have a chance to sit down with innovators, it’s in the margins of their day — instead of an exciting opportunity for change, a pitch-meeting with an innovator represents another 15 minutes they have to take from their family at the end of a long day, an extra 10 minutes of sleep lost in the morning to get into the office early, the interruption of the small respite of a lunch break.

It’s no surprise that in a 2018 survey conducted by the Physician’s Foundation, 89% of physicians polled felt that they had somewhat to very little influence on changes in healthcare — they have no time to research chances to optimize their practice, and thus essentially no voice in its improvement. Yet only a physician has the kind of intimate knowledge of his or her needs and workflow that can drive effective innovations. Perhaps digital innovations have failed to take hold because the people making decisions around tools to help doctors are not doctors.

If we are going to break the barriers to digital transformation in healthcare, we need to expect physicians to think critically about how their job needs to evolve. And no one can do this without time to reflect on and evaluate the status quo. In the corporate world, executives and other employees are encouraged to do research, to take time in their schedules for professional development. Many tech giants — most famously Google, but also Facebook, Linkedin, Apple, and others — employ the 20% time model, where roughly one-fifth of an employee’s schedule is focused on personal side projects (those side projects have turned into Gmail, Google Maps, Twitter, Slack, and Groupon, to name a few). This is the model that we need to embrace in the healthcare system.

We need to look past the excuse that “doctors are traditionally conservative” and that is why innovation is dead in the water. While that narrative may have explained why cutting edge technology is not more readily adopted by physicians, there are other problems that it doesn’t account for — like why rates of compliance for new protocols and best practices are abysmally low. Those symptoms should point us to a different solution, a solution we can do something about. Not “doctors need to get with the times” but doctors need to get some time.

One solution is to advocate for a higher price per consultation that can eliminate the existential need to pack daily schedules with patient appointments. Under the current model, doctors are incentivized to take as many appointments as possible, double — even triple — booking slots to squeeze as much productivity out of current rates of reimbursement. But with increased reimbursement per consultation, physicians can more easily cover the cost of their salaries for their employers, which can then allow providers to take more time out of the clinic and in the office, thinking critically about their roles and how to improve their delivery of care.

Of course, this begs the question — who pays? The ones who stand to benefit most, of course. Giving physicians more time to develop professionally and research solutions is in the best interest of those who take on the burden of health costs, health insurance providers and the government (ie, taxpayers). Patient outcomes are almost guaranteed to improve when physicians have the time to stay up to date on best practices, and this directly reduces the burden of cost on those stakeholders.

Physician salaries represent a very small part of healthcare costs, paling in comparison to drugs and diagnostic care. If more money was paid to the physician on the front end to develop and implement more preventative solutions — by payers or government subsidies — the cost savings would increase exponentially, making an increase in physician salary an astute business move as well as one that can have a dramatic impact on patients’ lives.

SOURCE: Pablo Segura, J. (11 October 2019) "Getting digital transformation in healthcare on the fast track" (Web Blog Post). Retrieved from https://www.benefitnews.com/opinion/getting-digital-transformation-in-healthcare-on-the-fast-track


Apple launching concierge health care centers for employees

Did you know Apple is now offering healthcare centers for their employees? Check out this article from Benefit Pro for further information.


This spring, Apple employees will see the first phase of Apple’s new approach to employee health care: on-site health clinics.

According to Healthcare IT News, Apple plans to launch a group of internal health centers as it moves to boost the health and wellness of its employees. According to the report, the company has already “quietly published a webpage for the program, called AC Wellness Network, which includes a description of the company’s goals as well as information on a number of open positions.”

“AC Wellness Network believes that having trusting, accessible relationships with our patients, enabled by technology, promotes high-quality care and a unique patient experience,” Apple has said on the webpage. It continues, “The centers offer a unique concierge-like healthcare experience for employees and their dependents. Candidates must have an appreciation for the patient experience and passion for wellness and population health—integrating best clinical practices and technology in a manner that drives patient engagement.”

Apple’s move comes in the wake of an earlier declared partnership among Amazon, JPMorgan Chase and Berkshire Hathaway for their own independent health care company intended to bolster employee health at lower cost than conventional providers.

AC Wellness, says the report, will exist as “an independent medical practice,” although the company is a subsidiary of Apple. Job listings include not just physicians but also such positions as workflow designers, and the website listings suggest the first centers will be located in Santa Clara, California and in the company’s Cupertino, California campus.

Other recent health care steps taken by the company, according to an HRDive report, include its January announcement that it is making personal health records accessible on the latest iPhones, as well as its exploration of ways its Apple Watch could have medical applications, like detecting irregular heartbeats in wearers.

According to a CNBC report, some former Stanford Health Care employees have been affiliated with AC Wellness for at least five months. Says Healthcare IT News, “[t]hese sources also said that Apple will use the centers as a testing ground for its upcoming health and wellness products prior to large-scale consumer rollout, and that the company notified third-party vendors this week about its upcoming health clinics.”

Read the article.

Source:
 Satter M. (1 March 2018). "Apple launching concierge health care centers for employees" [Web Blog Post]. Retrieved from address https://www.benefitspro.com/2018/03/01/apple-launching-concierge-health-care-centers-for/

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

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

What’s ahead for HR technology?

As technology modernizes business, HR has worked hard to keep up. In 2017, there were numerous innovations, so we can't wait to see what 2018 brings! Check out this article from Employee Benefit Advisor on some trends in HR Technology this year.


The past year saw a number of HR technology innovations and significant product introductions — and 2018 promises to bring about even bigger changes.

“The whole field of HRIS is really exciting right now,” says Vanessa DiMauro, CEO of consulting firm Leader Networks and a Columbia University faculty member. “There is so much change and innovation happening.”

Indeed, experts contend, innovations in artificial intelligence and analytics, along with development in cloud, social and mobile technologies, are making HR systems more intelligent and more engaging.

So what will smarter, friendlier HR systems do?

To begin with, they’ll provide more targeted support for employees by helping them gain access to the benefits and services they need. Employees with a new baby, for instance, would not only have their benefits packages updated automatically, but would also receive alerts and recommendations for store discounts, childcare facilities and other products and services geared toward helping them better manage their new family responsibilities.

Smarter HR systems also will deliver the type of workforce analytics that employers need to make better staffing decisions. The manager of a chain of convenience stores, for example, might want to schedule employees who have demonstrated a higher level of job performance for the late shift, because they can be counted on to close a store. The supervisor at a large hospital, on the other hand, might look to assign the facility’s most reliable employees — those who are more likely to show up for work on time — to care units that need to remain in compliance with their government-mandated staffing requirements.

But automatic updates and more efficient workforce scheduling are only two ways in which the latest digital advances will enhance human capital management. There are many others, including:

  • Increased employee retention and more effective recruitment.
  • Less biased performance management and KPIs.
  • Improved knowledge sharing and employee collaboration.
  • Greater workforce diversity and inclusion.

To illustrate this, DiMauro points to a new set of talent acquisition tools aimed at helping employers take advantage of underutilized labor pools by increasing the diversity of their workforce. These include applications to help improve outreach efforts to military veterans and people with disabilities, among other populations.

Offering another example, she cites an emerging category of applications designed to minimize gender, ethnic and other forms of bias, when it comes to performance reviews and considering employees for raises and promotions.

Building a smart system

What gives these new applications their power and joins them together, as part of an integrated HR information system (HRIS), is their ability to feed and draw from the same set of employee records. Building this smart HR system — and setting forth on the employer’s digital “journey,” of which it is a part — is likely to begin with the deployment of an employee-collaboration or knowledge-management platform that serves as the hub for all of the employer’s future HR tech endeavors.

The knowledge platform is linked through a single sign-on to the organization’s employee records database. HR staffers and other employees can organize the information into groups, which employees can join. A new hire might begin by logging into the “new employee orientation” group, which might auto-join the employee into a “benefits” group or a “training” group.

Over time, employees can continue to be auto-joined to different groups and auto-fed applicable content, as they experience different life events (such as a home purchase) or reach various milestones (such as a promotion) in their careers. Each of the groups might be built around a corresponding app — some of which might be designed for a mobile device.

Utilizing a hub and spoke model, different HR applications can be added to the system and tied into the employee database. In this way, employers are able to incrementally build out a 360-degree HRIS “wheel” that eventually includes performance reviews, employee engagement portals and talent acquisition tools that auto-reward employees for successful referrals.

The auto-classification and auto-taxonomy features embedded in the collaboration platform and corresponding apps, DiMauro explains, eliminate many of the purely rote administrative tasks that HR is saddled with today.

Meeting employee needs

Citing consumer research, the consultant notes that most customers — including most employees — want to self-serve. “Who wants to wait until morning, if you have a middle-of-the-night problem?” she asks. “When employees can readily find their own answers to less complex questions, that is a win-win for both the employee and the HR rep who would’ve had to handle the request.”

Behind all these innovations are a number of new technologies that will continue to gain steam in 2018. The most important of these is the cloud.

“From a technology standpoint, this is the biggest trend in HRIS,” says Lisa Rowan, vice president for HCM and talent management at market researcher International Data Corp.

Cloud-based HRIS solutions, which are hosted at remote facilities and maintained by the service provider, offer employers many advantages over traditional on-premise solutions that they had to maintain themselves. Chief among these are lower maintenance costs, faster transaction times, a more streamlined and easier-to-use interface, and software that is always up to date.

Human resource execs are embracing applicant tracking, training management, performance management and other software applications.

Keeping HRIS software current is important, if the employer wants to take advantage of other leading-edge technologies as they become available, including more graphically-oriented, intuitive applications for complex undertakings like a benefits enrollment. But it does require certain tradeoffs.

Traditionally, if an HRIS system didn’t support the precise way an HR organization handled a given task or function, custom software code would be written to adapt the system to the process. This was expensive and time-consuming, and forced companies to delay adopting new versions of the software, since every upgrade required complex rewrites of their customized code. Cloud-based systems eliminate these requirements and are much easier to deploy, but the HR department must adapt to the workflow prescribed by the system — and not the other way around.

As cloud-based systems become prevalent, says Rowan, “HR professionals will have to face the fact that they will have to do things a little differently to fit within the scope of a configurable, but not customizable, system.”

The cost efficiencies and operational advantages associated with a cloud-based system pave the way for other break-through HRIS technologies as well. Chief among them are:

  • Social media, which offers employees new ways to share work and collaborate, and provides employers with new tools for disseminating their message and attracting job candidates.
  • Mobile devices, which let employers tailor their outreach to select groups of employees, and allow employees to clock-in, enroll for benefits and handle many other tasks remotely, at a time and place of their choosing.
  • Artificial intelligence, which is paving the way for new and different ways to respond to employee demands. Chat boxes, for instance, will soon replace human operators at HR call centers. Employees who phone or text in will still feel as though they are dealing with a person, but it will be a computer algorithm at the other end of the line.
  • Data analytics, which give HR pros tools to gauge and influence employee behaviors, improve open enrollment outcomes and deepen employee engagement. But data analytics can also be utilized in a more strategic manner: By correlating workforce composition and activity with specific business outcomes, employers can systematically reshape their workforce to improve those outcomes.

“Analytics allow employers to identify useful trends by asking simple questions,” explains Bob DelPonte, general manager for the workforce ready group at Kronos, a provider of human capital management products and services. “For example, what’s the turnover rate for employees who live more than 20 miles away from work, compared with those who live less?”

The answer, he says, can inform the employer’s hiring and scheduling decisions. “Why risk losing a hard-to-replace employee because you’re forcing her to travel farther than she needs to, if you have the option of transferring her to a closer facility?”

Proceeding with caution

While technologies like artificial intelligence can be a boon to HR, they can also pose challenges. By increasing automation, AI will free HR staff from many repetitive tasks, allowing them to focus on more strategic concerns. But analysts like Rowan are not demure about the fact that some HR staffers will also be replaced by the software.

“How does that play out?” she asks. “You have HR personnel today who are geared toward answering phone calls, and when there are fewer calls, they may no longer be needed. There’s no point to sugar-coating that reality. There are HR professionals that need to think about re-skilling themselves.”

DiMauro also offers a word of caution. “It’s important that HR executives don’t get drunk at the bar of tools. There are so many new applications,” she says, “that they need to keep their wits about them and determine what they really need. Look for the right tool to solve the problem. Don’t just collect and decorate because it’s all out there and available.”

Read the original article.

Source:
Kass E. (17 January 2018). "What’s ahead for HR technology?" [Web Blog Post]. Retrieved from address https://www.employeebenefitadviser.com/news/whats-ahead-for-hr-technology?feed=00000152-175f-d933-a573-ff5f3f230000

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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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