The FDA Takes On Mobile Health Apps
Posted: September 12, 2012 at 8:17 pm
12 September 2012The mobile health industry has a problem: It has grown too quickly. Consumers can now download medical apps for at-home monitoring of just about any obscure ailment, and apps for general wellness, diet, and fitness are proliferating. According to one recent count, the iTunes app store now contains 13 000 health and wellness apps.
But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While its assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions.
Thats about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape theyll encounter in the future, but theyre also nervous that overly broad rules will stifle innovation.
While waiting for the final guidelines to be published, we surveyed notable industry figures on what theyd like to see in the rules. Here are their top-five requests to the FDA.
1. Clarify the difference between a medical app and a wellness app.
The FDA has the authority to regulate medical devices and software that diagnose or treat disease, but not those that simply contribute to general wellness. However, the line between these two categories has been blurred as people have gained a better understanding of how daily life choices contribute to disease risk.
Take the example of a workout-tracking app, says Brad Thompson, a health-care lawyer with the firm Epstein Becker & Green and general counsel for the mHealth Regulatory Coalition. An app that records how many miles I run in a given week is just an exercise app, he says. But if that same app says, If you are challenged by obesity, you need to exercise more, and you can use this app to track your exercise, then its linked to a disease. By presenting exercise as a treatment for the disease of obesity, the app may have crossed the line from a wellness app to a medical app. Once the FDA has more clearly defined the line, says Thompson, app makers will have to be more careful with their marketing claims.
2. Clarify the difference between diagnosing and monitoring.
If an app allows a user to take a picture of a mole on his skin and it tells him if he has melanoma, thats clearly a medical app thats subject to FDA oversight, says Ben Chodor, the CEO of Happtique. His company curates the health and wellness apps in the iTunes store to help users find the most effective offerings, and it is trying to establish an app prescription system for doctors. But what if an app offers a photo gallery of skin conditions, including photos of melanoma? If it doesnt provide a diagnosis, is it just a reference guide? Thats a gray area, Chodor says. Thats where developers come to us and say, Hey, do we need to go to the FDA for certification?
3. Establish the risk-level threshold for FDA enforcement.
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The FDA Takes On Mobile Health Apps
ACE Launches New Health Coach Certification
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SAN DIEGO--(BUSINESS WIRE)--
Despite 29,365 health and fitness clubs nationwide, two new FDA-approved diet pills and numerous fad diets that sell quick-fix solutions, the number of overweight and obese Americans has continued to climb to more than 67 percent, according to data from IBISWorld and the Centers for Disease Control & Prevention.
In an effort to provide a better solution to a problem that impacts everything from insurance costs to preventable disease, American Council on Exercise (ACE) has launched the ACE Health Coach certification.
Fad diets, over-the-counter medication and gym memberships with limited guidance arent effective solutions for people who have lived their entire lives overweight or obese, said ACE Chief Science Officer Cedric Bryant. Those people dont just need an exercise program or a diet plan. They need an expert who can guide and empower them. They need someone who can connect with them in a way that makes them not only want to change, but believe they have the ability to make meaningful and lasting changes.
Intended for fitness, wellness, health care, human resources and allied health professionals who want to make a resounding difference in the way people live, the NCCA-accredited certification emphasizes fitness, nutrition and the science behind true behavior modification.
ACE Health Coach is designed to address a change in the way people view overall health.
The ACE Health Coach certification reflects what we believe to be the true measure of health and well-being, Bryant said. Living your most fit life doesnt come from just changing the way you eat or altering your schedule to include a few weekly workouts. To truly be fit physically as well as in mind and spirit means achieving balance, strength, agility, coordination and endurance in everything you do. Those Tools for Life, as ACE calls them, extend far beyond weight loss.
Information about the ACE Health Coach exam will be available beginning today on ACEfitness.org. The newly published ACE Health Coach Manual: The Ultimate Guide to Fitness, Wellness and Lifestyle Change features content by fitness and industry leaders including award-winning personal trainer Jonathan Ross, behavioral psychologist Dr. Michael Mantell and registered dietitian Natalie Digate Muth, MD, MPH.
The ACE Health Coach credential serves as a critical missing link between fitness, medical, allied health and wellness professionals, Bryant said. It will provide the knowledge and skills needed to inspire, motivate and encourage individuals to make healthy living an integral part of their lifestyles.
About ACE
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ACE Launches New Health Coach Certification
University of Utah – Utah Football – Jordan Wynn Press Conference – 09/11/12 – Video
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Personal Finance Daily: How to save enough for retirement
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By MarketWatch
Dont miss these top stories:
By the time you retire at age 67, you should have eight times your salary saved for retirement, in order to replace 85% of pre-retirement income. Youre on track to cover basic retirement expenses if, at 35, you have one full year of current salary saved up and if you continue saving at a specified rate.
Thats according to a new retirement tool from Fidelity Investments, which Andrea Coombes writes about in her latest column. To be fair, any tool that claims it can tell you how much you need to save is making some assumptions that may not fit your situation, and by following the guidelines, you may end up saving not enough or too much, she writes.
Read the full column in todays Personal Finance pages, along with more retirement coverage from Robert Powell and Chuck Jaffe. Plus, read about the latest Census Bureau statistics that indicate median household income decreased last year, and 46 million Americans remained in poverty.
Amy Hoak , Personal Finance Daily
Are you saving enough for retirement? A new tool aims to give savers a rough guide to let them know whether theyre on trackbut, as with all retirement tools aimed at a broad audience, take the information with a grain of salt. Retirement savings: How much is enough?
With the Fed likely to launch QE3, experts are suggesting that there might be some different moves to make with your money, especially if you are retired or fancy retiring. 7 QE3 moves to make with your money.
Before politicians can fix Social Security, they need to ensure that older Americans feel more secure about their financial future due to the fruits of their own labor, rather than any form of entitlement, writes Chuck Jaffe. For a better retirement, work longer.
Doctor develops new system to allow older people to remain at home, while providing them with cost-effective services using technology and a combination of volunteer and paid labor. Seniors get wired to stay home.
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Personal Finance Daily: How to save enough for retirement
Research and Markets: GlaxoSmithKline Plc in Beauty and Personal Care (World) – An Analysis of the Company's …
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DUBLIN--(BUSINESS WIRE)--
Research and Markets (http://www.researchandmarkets.com/research/85j2rw/glaxosmithkline_pl) has announced the addition of the "GlaxoSmithKline Plc in Beauty and Personal Care (World)" company profile to their offering.
GSK remains a small player in the vast beauty and personal care industry due to its focus on oral care. The company's strong background in pharmaceuticals and consumer health offers it potential in developing health-orientated beauty products. This report analyses the company's performance in 2011 with focus on oral care and evaluates its growth potential in the near future.
Euromonitor International's GlaxoSmithKline Plc in Beauty and Personal Care (World) Company Profile offers detailed strategic analysis of the company's business, examining its performance in Beauty and Personal Care industry. The report examines company shares by region and sector, product developments, market and distribution strategies, challenges from the competition and future prospects. Use it to understand opportunities and threats facing the business and the factors driving success.
Why buy this report?
- Get a detailed picture of the Beauty and Personal Care market;
- Pinpoint growth sectors and identify factors driving change;
- Understand the competitive environment, the market's major players and leading brands;
- Use five-year forecasts to assess how the market is predicted to develop.
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How your personal brand will help or hinder your career
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Reproduced from The Power of Personal Branding for Career Success, with permission from the publisher, The Canadian Institute of Chartered Accountants. 2012. All rights reserved.
Walking down the street and thinking about a cup of coffee, you see Tim Hortons, Starbucks and your local independent coffee shop. Chances are good that you will make up your mind very quickly because you already have a brand preference and your preference will likely be the same a day or even a month later. This type of decision-making is not very surprising, considering the extensive marketing efforts of the two national chains (and, to a lesser degree, the local coffee shop) to attract niche customers, understand their values and build the brand. In fact, all decisions made by each business entity on pricing, product range, dcor and advertising are based on that predetermined brand.
Video: Why its up to you to manage your career
This book is about using the same brand strategy to advance your career. Your first reaction may be brand? How does my career resemble selling coffee? Of course, your career is much more complex and personal than coffee you are not just a product. However, you are a product in the sense that branding is just as critical a component in marketing yourself as it is in marketing a product. The concept of branding positioning yourself for success is a good lens through which to focus on your career strategy.
Choosing and developing your personal brand will help you get where you want to go. Wherever you are in your career starting out, in the middle or in a senior position the concepts and strategies presented throughout these chapters will help you articulate and achieve your goals. The focus is on strategies for advancing your career but applies equally to realizing other goals, such as volunteer activities or community works.
Lets return to product branding and look at some questions that come to mind when considering its effectiveness. Think about one of your favourite products that has a well-recognized brand:
How is the product differentiated from its competitors?
How well known is the product?
What adjectives come to mind if you were to describe or recommend this product?
Does the brand effectively make use of the attributes of the product?
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How your personal brand will help or hinder your career
Stand out from the pack and advance your career – New book shows you how to build your brand
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TORONTO, Sept. 12, 2012 /CNW/ - What people say about you when you are not in the room can hold the key to career success, according to a new book from the Canadian Institute of Chartered Accountants (CICA), published in conjunction with Ernst & Young.
The Power of Personal Branding for Career Success provides a step-by-step plan to help establish a true personal brand that will resonate long after you leave a meeting. The book also outlines how to market your skills and expertise to advance your career.
The author is Karen Wensley, a recently retired partner at Ernst & Young who served as the firm's national people team leader.
"In today's marketplace, where competition for top jobs is fierce, your personal brand must be carefully honed and strategically guarded if you want to advance," explains Wensley. "Your brand says a lot about who you are, and the real value you can bring to an organization, so you must invest in it if you want to succeed."
The book proposes an eight-step process, complete with real-world anecdotes, examples and worksheets to help you start establishing a personal brand for career success.
Cairine Wilson, vice-president, member services, CICA, says CAs have been asking for this type of valuable career resource. "In a results-oriented organization, you want to be seen as making a difference," says Wilson. "CAs and others need creative and strategic ways to be recognized to advance their careers."
Stephen Shea, CA, Canadian managing partner, people, at Ernst & Young, stresses that it is important to be proactive. "We have a role to play in shaping how we are perceived by others. If we cannot define ourselves, others will do it for us," he notes.
The Power of Personal Branding for Career Success is available in both French and English. More information about the book, including how to order a copy, can be obtained online at http://www.CAstore.ca/personalbranding-wb.
About CICA Chartered Accountants (CAs) are Canada's most valued, internationally recognized profession of leaders in senior management, advisory, financial, tax and assurance roles. Through their integrity, expertise, and internationally recognized qualification standards, Canada's 82,000 CAs sustain their influence and leadership position both in Canada and globally. As trusted business advisors to Canadian organizations of all sizes, Canada's CAs foster confidence in Canadian business and contribute to the health and sustainability of Canada's capital markets and economy. The Canadian Institute of Chartered Accountants (CICA) represents Canada's CA profession both nationally and internationally. The CICA is a founding member of the International Federation of Accountants (IFAC) and the Global Accounting Alliance (GAA).
About Ernst & Young Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide, our 152,000 people are united by our shared values and an unwavering commitment to quality. We make a difference by helping our people, our clients and our wider communities achieve their potential.
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Stand out from the pack and advance your career - New book shows you how to build your brand
From "Chubby Cheerleader" to Sleeve Success with Dr. Michael Feiz
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LOS ANGELES, Sept. 12, 2012 /PRNewswire/ -- Research will get you everywhere according to a patient named Sasha, whose own blog now spreads the word about quality bariatric surgery. Her weight loss adventure has led to blind alleys and personal disasters, but after careful Internet research she found herself in good hands.
Now the 26-year-old is making advances every day as she cruises swiftly toward her goal weight. While Sasha's grit and determination deserve much of the credit, sleeve gastrectomy from Los Angeles' go-to bariatric surgeon Dr. Michael Feiz was a major part of getting where she needed to be.
Trouble began in high school, when the "Chubby Cheerleader" label was first applied. That was when she first started to feel body image-related social pressures. "I was a bigger girl. I'm 5'8'', but high school girls suddenly feel so much pressure to fit into a certain dress size."
Research steered Sasha toward many options. "Embracing your bigger body works for some people," she said, and she applauds those who are healthy and comfortable that way. She was concerned about a family history of diabetes and other health concerns, though. "I didn't want to remember The Chubby Cheerleader. I wanted to be healthy."
The LAP Band is frequently the answer for those who similarly need the health and confidence that comes with weight loss. Sasha's LAP Band experience, however, was far from ideal. "I lost 20 pounds," she says. In other words: her weight loss was far from ideal, and it was accompanied by nausea and discomfort. Then she found out that her doctor, someone from a popular and heavily advertised weight loss surgery company, wasn't even board certified. "I just wanted it out," she says.
Dr. Feiz was different. At Sasha's free consultation, she felt her concerns were being heard. "I wasn't just being shuffled through," she said. She was also being presented with a variety of options, including vertical sleeve gastrectomy. Dr. Feiz removed her LAP Band, and offered to put another one in place so that her weight loss would continue. Another LAP Band wasn't a tempting prospect, and she turned it down. A few months later when the weight had returned, Sasha asked for a new solution, and Dr. Feiz recommended the gastric sleeve at the Huntington Beach surgery center.
"Doctor Feiz told me about the recovery, and he said he'd be happy to take my phone call when I was irritable and uncomfortable." She felt these effects, briefly. But on day 4 she was walking around. After just over two weeks, she's energetic and eager to share her experience with others.
Most importantly however, she's lost 15 pounds since the day she went for surgery two weeks ago, and even with water weight the weight from surgery included 15 pounds is impressive, and most likely a preview of things to come.
To find out about the work being done by Dr. Feiz and his partners, visit them online at http://www.drfeiz.com.
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From "Chubby Cheerleader" to Sleeve Success with Dr. Michael Feiz
Course Builder Intro Video – Video
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