A blog covering the health/care ecosystem and people.

Patients in the U.S. are transforming into health care consumers, and in 2015 there are 3 underlying forces shaping that new consumer. This week kicks off the annual BIO conference in Philadelphia, and today Klick Health, the digital communications firm, convenes a group of thought leaders in healthcare to brainstorm markets, financing, and the state of pharmaceutical and life science innovation. An underlying theme throughout this meet-up is patient’s role in health/care. Patients are people, consumers, caregivers, mothers, fathers, sisters, brothers, friends, neighbors, community members, taxpayers, all. We’re old, we’re young, we’re mobile and not-so-much, we’re amputees, we’re migraneurs, we’re cancer

People in the U.S. spend over five-and-a-half hours a day with digital media in 2015, with time on mobile devices exceeding use of laptop and desktop computers. The growth of mobile means people are using and seeking more just-in-time services in daily living, and this has big implications for health/care, based on the annual mega-report on Internet Trends from Mary Meeker, KPCB’s internet analyst. “People” in health/care are patients, consumers and caregivers; people in health/care are also health plan administrators, employer benefits managers, doctors, nurses, allied health professionals, financial managers in hospitals, pharmacists, and the entire range of humans who

The spiritual and emotional top the physical in women’s definition of “health,” based on a multi-country survey conducted in Brazil, Germany, Japan, the UK and the U.S. The Power of the Purse, a research project sponsored by the Center for Talent Innovation, underscores women’s primary role as Chief Medical Officers in their families and social networks. The research was sponsored by health industry leaders including Aetna, Bristol-Myers Squibb, Cardinal Health, Eli Lilly and Company, Johnson & Johnson, Merck & Co., Merck KGaA, MetLife, Pfizer, PwC, Strategy&, Teva, and WPP. The study’s summary infographic is titled How the Healthcare Industry Fails

The number of people in the U.S. spending over $100,000 a year on prescription drugs tripled in 2014, according to Super Spending: U.S. Trends in High-Cost Medication Use, from The Express Scripts Lab. Express Scripts is a pharmacy benefits management company that manages over one billion prescriptions a year. The company analyzed prescription drug claims for 31.5 million health plan members for this study, in commercially insured, Medicare, and Medicaid plans. The big-dollar story in 2014 was Hepatitis C, with a relatively small patient population but a super-sized drug spend as the first chart shows: a very tall blue bar (Rx

The costs of healthcare in the U.S. have trended upward since 2000, with a slowdown in cost growth between 2009 to 2013 due to the impact of the Great Recession. That’s no surprise. What stands out in the new U.S. News & World Report Health Care Index is that people covered by private health insurance through employers are bearing more health care costs while publicly-covered insureds (in Medicare and Medicaid) are not. Blame it on the fast-growth of high-deductible health plans, the Index finds, resulting in what U.S. News coins as a “massive increase in consumer cost.” U.S. News &

Living my mantra of Health is Everywhere, where we live, work, play, pray, and shop, I am always on the lookout for signs of health in my daily life. Today I’m in Washington, DC,  speaking on a webinar led by the National Council on Patient Information and Education (NCPIE), discussing the findings in a survey of U.S. adults on self-care health care – my shorthand for healthcareDIY. And the hashtag for the webinar also speaks volumes: #OwnYourHealth. Here’s the link to the survey resources. On my walk from Farragut North Metro station to a nearby office where the meeting will take place,

Alex Gourley, President of The Walgreen Company, addressed the capacity crowd at HIMSS15 in Chicago on 13th April 2015, saying his company’s goal is to “make good health easier.” Remember that HIMSS is the “Health Information and Management Systems Society” — in short, the mammoth health IT conference that this year has attracted over 41,000 health computerfolk from around the world. So what’s a nice pharmacy like you, Walgreens, doing in a Place like McCormick amidst 1,200+ health/tech vendors?  If you believe that health is a product of lifstyle behaviors at least as much as health “care” services (what our

As much as the Affordable Care Act is bolstering health insurance rolls for the uninsured, people who have enjoyed health insurance at work continue to highly value that benefit, according to a survey from Benz Communications and Quantum Workplace published April 2015. Based on a national sample of over 2,000 employees surveyed in October 2014 about workplace benefits. The research re-confirms the long-term reality of workers working in America for the health benefit. Benz/Quantum note that 89% of workers say health benefits play a part in remaining on-the-job, and half say the health benefit is a “major” part of remaining

There’s a trifecta of books written by three brilliant doctors that, together, provide a roadmap for the 21st century continuum of health care: The Patient Will See You Now by Eric Topol, MD; The Digital Doctor from Robert Wachter, MD; and, Being Mortal, by Atul Gawande. Each book’s take provides a lens, through the eyes of a hands-on healthcare provider, on healthcare delivery today (the good, the warts and all) and solutions based on their unique points-of-view. This triple-review will move, purposefully, from the digitally, technology optimistic “Gutenberg moment” for democratizing medicine per Dr. Topol, to the end-game importance of

While there’s little evidence that the short-term impact of the Affordable Care Act has limited job growth or driven most employers to drop health insurance plans, the ACA has spawned a “cottage industry” of health companies since 2010, according to PwC. As the ACA turned five years of age, the PwC Health Research Institute led by Ceci Connolly identified at least 90 newcos addressing opportunities inspired by the ACA: Supporting telehealth platforms between patients and providers, such as Vivre Health Educating consumers, such as the transparency provider HealthSparq does Streamlining operations to enhance efficiency, the business of Cureate among others

As people take on self-service across all aspects of daily living, self-care in health is growing beyond the use of vitamins/minerals/supplements, over-the-counter meds, and trying out the blood-pressure cuff in the pharmacy waiting for a prescription to be filled. Today, health consumers the world over have begun to engage in self-care using digital technologies. And this isn’t just a phenomenon among people in the Millennial generation. Most seniors who regularly use technology (e.g., using computers and mobile phones) are also active in digitally tracking their weight, for example, learned in a survey by Accenture. Older people who use technology in daily

The 87th annual 2015 Oscars show (#Oscars15) feted more than the movie industry: the event celebrated health in both explicit and subtle ways. Julianne Moore took the golden statuette for Best Actress, playing the title role in Still Alice, the story a woman diagnosed with early-onset Alzheimer’s Disease. In accepting her award, Moore spoke of the need to recognize and “see” people with Alzheimer’s – so many people feel isolated and marginalized, Moore explained. Movies help us feel seen and not alone – and people with Alzheimer’s need to be seen so we can find a cure, she asserted. See Moore’s lovely

Just 1 in 5 health-insured people with a primary care provider use the web to look at their health data, and fewer than 1 in 10 people use digital means to book appointments. Welcome to the 2015 State of the Connected Patient, a survey report from Salesforce conducted by Harris Poll among 2,095 adults in January 2015. Perhaps the title of the analysis should more appropriately be the “2015 State of the Unconnected Patient.” While most patients polled are satisfied with their PCPs and most believe doctors are sharing their health records, people lack digital engagement with their primary care providers.

Long an advocate for consumer-directed health in his company, John Mackey, co-CEO and co-Founder of Whole Foods Market, is talking about expanding the food chain’s footprint in retail health. “Americans are sick of being sick,” Mackey is quoted in “Whole Foods, Half Off,” a story published in Bloomberg on January 29, 2015. Mackey talks about being inspired by Harris Rosen, a CEO in Florida, who has developed a workplace clinic for employees’ health care that drives high quality, good outcomes, and lower costs. Mackey imagines how Whole Foods could do the same, beginning in its hometown in Austin, TX. He

“Health care spending grows at lowest-ever rate,” USA Today celebrated in their December 3, 2014 headline. The announcement was drawn from national health spending data gleaned from an annual report from the Centers for Medicare and Medicare Services (CMS), which tallied U.S. health spending at $2.9 trillion. From the bird’s-eye view, slowing healthcare cost growth is indeed good news. But from the point-of-view of consumers’ own pockets, health care costs are rising. And, a survey published today by Gallup points to this reality: that people in American say the most important financial problem they face is healthcare costs, tied for first place

Are you Feelin’ Groovy about wearables? Well slow down, you move too fast… …at least, according to Accenture’s latest survey into consumers’ perspectives on new technologies, published this week in conjunction with the 2015 Consumer Electronics Show in Las Vegas, the largest annual convention in the U.S. featuring technology for people. At #CES2015, we’re seeing a rich trove of blinged-out, multi-sensor, shiny new wearable things at the 2015 Consumer Electronics Show. Swarovski crystals are paired with Misfit Wearables, called the Swarovski Shine, shown here as a shiny new thing, indeed. Withings launched its Activite fitness tracking watch in new colors.

‘Tis the season for annual health trendcasting, which is part of my own business model. Here’s a curated list of some of my favorite trend reports for health care in the new year, with my Hot Points in the conclusion, below, summarizing the most salient trends among them. TechCrunch’s Top 5 Healthcare Predictions for 2015: In this succinct forecast, Walmart grows its presence as a health plan, startups get more pharm-funding, hospitals channel peer-to-peer lending, Latinos emerge as a “most-desired” health care segment, and Amazon disrupts the medical supply chain. Experian 2015 Data Breach Forecast: Healthcare security breaches will be

The Field of Dreams works in nostalgic plotlines about baseball, but as I’ve pointed out since the advent of consumer-facing health technologies, there’s no Field of Dreams effect in health care when it comes to consumer health engagement. U.S. health consumers aren’t using the patient portals that health care providers have built as part of their efforts to bolster health engagement via EHRs and health IT, Xerox found in the company’s 5th annual survey on electronic health records. I spoke with Tamara St. Claire to discuss the implications of the consumer poll, which was conducted among 2,017 U.S. adults in

“Disruption” is a well-used word these days in business and, in the past few years, in the health care business. That’s because there’s a general consensus that the U.S. health care system is broken. “System” is a word that I shouldn’t use as my friend J.D. Kleinke smartly argued that it’s that lack of system-ness that makes using the phrase “health care system” an Oxymoron. The fragmented health care environment creates innumerable pain points when accessing, receiving, and paying for services. And it’s women who feel so much of that pain. In that context, I’m gratified and humbled to be one

This post is written as part of the Disruptive Women on Health’s blog-fest celebrating the 2014 mHealth Summit taking place 7-11 December 2014 in greater Washington, DC. Women and mobile health: let’s unpack the intersection. On the supply side of the equation, Good Housekeeping covered health tracking-meets-fashion bling in the magazine a few weeks ago in article tucked between how to cook healthy Thanksgiving side dishes and tips on getting red wine stains out of tablecloths. This ad appeared in a major sporting goods chain’s 2014 Black Friday pre-print in my city’s newspaper last week. And along with consumer electronics brand faves like

The corporate reputation, brand equity, of the health insurance continues to be low relative to other financial service industry benchmarks, found in the ACSI Finance and Insurance Report 2014. Customer satisfaction with health insurance companies fell between 2013 and 2014, especially attributed to higher costs hitting consumers in group (employer-based) policies. The 2014 American Customer Satisfaction Index (ACSI) is informed by interviews with 6,819 consumers interviewed via phone and email between July and September 2014. Customers of financial services companies (banks, credit unions, health insurance, life insurance, property & casualty, and internet brokerages) were asked to provide their opinions about named-firms

“A wearable future is around the corner,” PwC says. So it’s appropriate the consulting firm’s new report is indeed titled The Wearable Future. Wearable technologies — smartwatches, sensor-laden workout gear, activity tracking wristbands, and Google Glass, among them — are more than individual tracking and information devices. They’re part of a larger ecosystem called The Internet of Things (IoT), which is made of lots of stuff, each ‘thing’ incorporating a sensor that measures something. Those measurements can track virtually everything that someone does throughout the day: beyond the obvious steps taken, hours slept, and GPS coordinates, sensors can sense movement

The health care industry is undergoing a retail transformation, according to Retail Reigns in Health Care: The rise of consumer power and its organization & workforce implications from Deloitte. Deloitte’s report published in October 2014 focuses on the health insurance business, which is newly-dealing with uninsured people largely unfamiliar with how to evaluate health plan options. This by any definition requires new muscles for both buyers and sellers on a health insurance exchange: new product access + uninformed consumer = retail challenge. Deloitte notes another supply and demand challenge, and that’s with the health insurance company workforce: while 93% of health

This past weekend, 60 Minutes’ Leslie Stahl asked John Castellani, the president of PhRMA, the pharmaceutical industry’s advocacy (lobby) organization, why the cost of Gleevec, from Novartis, dramatically increased over the 13 years it’s been in the market, while other more expensive competitors have been launched in the period. (Here is the FDA’s announcement of the Gleevec approval from 2001). Mr. Castellani said he couldn’t respond to specific drug company’s pricing strategies, but in general, these products are “worth it.” Here is the entire transcript of the 60 Minutes’ piece. Today, Health Affairs, the policy journal, is hosting a discussion

National health spending will comprise 19.3% of U.S. gross domestic product in 2023, nearly $1 in $5 of all American spending. This statistic includes the expenditure categories for health spending as defined by the Centers for Medicare and Medicaid Services (CMS), Office of the Actuary. The number includes hospital care, personal health care, professional services (physicians and other professionals), home health, long term care, retail sales of prescription drugs and durable medical equipment, and investment in capital equipment, among other line items. The forecast was published in Health Affairs article, National Health Expenditure Projections, 2013-23: Faster Growth Expected With Expanded

It’s de rigueur for any organization marketing a product or service in health care to be “patient-centered” these days. “Patient engagement” and “health engagement” are phrases found on health conference agendas, whether pitching to attendees in pharma and life sciences, health IT, health insurance, or healthcare (to hospitals and physicians, alike). One paradigm for patient-centricity that’s more mature than most is IMS Health’s Patient Journey construct, which the data-driven company has been talking about since 2012. While the concept focused mainly on pharmaceutical marketing and medication adherence, it’s useful for all industry segments looking to motivate behavior change in health

In the past few weeks, several events bolster the reality that health and health care are in Blurred Lines mode. Not Robin Thicke Blurred Lines, mind you, but the Venn Diagram overlapping kind. Walmart launched real primary care clinics in South Carolina and Texas. These will provide services beyond urgent care, charging $4 a visit for company employees and $40 a visit for other people The U.S. Department of Agriculture issued a report promoting “nudges” to grocery shoppers enrolled in the Supplemental Nutrition Access Program (SNAP) to buy healthy foods Apple is talking with Cleveland Clinic, Johnson Hopkins, and Mount Sinai Medical

In the post-Recession American economy, people shop for value in all things. And that includes health care services like MRIs — when patients are informed of pricing differences among imaging facilities and given free rein to pick-and-choose among them. In addition to lowering imaging costs in a community, price transparency also generated competition between providers. Health Affairs published this research detailed in Price Transparency for MRIs Increased Use of Less Costly Providers And Triggered Provider Competition in August 2014. An Economics 101 course teaches us that a well-oiled (perfect) market depends on lots of sellers of a product and lots of

Make-over your medicine cabinet. That’s a key headline for International Self-Care Day (ISD) on July 24, 2014, an initiative promoting the opportunity for people to take a greater role in their own health care and wellness. Sponsored by the Consumer Healthcare Products Association (CHPA), consumer products companies, health advocacy organizations, and legislators including John Barrow (D-GA), a co-sponsor of H.R. 2835 (aka the Restoring Access to Medications Act), the Day talked about the $102 billion savings opportunity generated through people in the U.S. taking on more self-care through using over-the-counter medicines. After the 2008 Recession hit the U.S. economy, industry analysts

3 in 5 people in the U.S. would like to take the lead on making medical decisions for themselves, according to the Altarum Institute Survey of Consumer Health Care Opinions, Spring 2014 edition, published July 2014. Another 30% of people want to make a joint decision with equal input from their doctor. Together, the math calculates to 9 in 10 Americans seeking major roles in medical decisions. Altarum’s survey paints a picture of consumers looking to take charge in health care, seeking information about symptoms and clinical issues. 7 in 10 people look up health information before seeing their doctor,

A vast majority of people shopping for a health plan on a Health Insurance Exchange for coverage in 2014 obtained information online via websites. One-half of these shoppers used only online information, and 29% combined both websites and other sources like direct assistance, informal assistance, and via (offline) media. In the Health Reform Monitoring Survey from the Urban Institute Health Policy Center, a research team, funded by the Robert Wood Johnson Foundation and the Ford Foundation, looked into data collected from the Health Reform Monitoring Survey in March 2014 at the end of the 2014 open enrollment period for the

Tomorrow is World No Tobacco Day. The use of tobacco is one of the most preventable public health issues on the planet. And the global tobacco epidemic contributed to 100 million deaths around the world in the 20th century. 6 million people die every year due to tobacco use — including 600,000 deaths due to exposure to secondhand smoke. About 500 million people living today will be dead from the use of tobacco products if current smoking habits continue, the World Health Organization (WHO) expects. WHO sponsors the World No Tobacco Day every year on May 31. For this year’s

“The surge in HDHP enrollment is causing patients to become consumers of healthcare,” begins a report documenting the rise of patients making more payments to health providers. Patients’ payments to providers have increased 72% since 2011. And, 78% of providers mail paper statements to patients to collect what they’re owed. “HDHPs” are high-deductible health plans, the growing thing in health insurance for consumers now faced with paying for health care first out-of-pocket before their health plan coverage kicks in. And those health consumers’ expectations for convenience in payment methods is causing dissatisfaction, negatively affecting these individuals and their health providers’

Yesterday kicked off this week in Health Populi, focusing on the growing role of transparency in health care in America. Today’s post discusses the results from Change Healthcare’s latest Healthcare Transparency Index report, based on data from the fourth quarter of 2013, published in May 2014. Charges for health services — dental, medical and pharmacy – varied by more than 300% in Q42013 — even within a single health network. Change Healthcare found this, based on their national data on 7 million health-covered lives. The company analyzed over 180 million medical claims. The company built the Healthcare Transparency Index (HCTI)

The Consumer Electronics Association (CEA) has formed a new Health and Fitness Technology Division, signalling the growing-up and mainstreaming of digital health in everyday life. The CEA represents companies that design, manufacture and market goods for people who pay for stuff that plugs into electric sockets and operate on batteries — like TVs, phones, music playing and listening, kitchen appliances, electronic games, and quite prominent at the 2014 Consumer Electronics Show, e-cigarettes (rebranding “safe smoking” as “vaping” technology). In its press release announcing this news, CEA President and CEO Gary Shapiro says, “Technology innovations now offer unprecedented opportunities for consumers to

Employer wellness programs are growing in the U.S., bundled with consumer-directed plans and health savings accounts. A wellness company’s work with employee groups is demonstrating that workers who adopt mobile health technologies — especially “wearables” coupled with smartphone apps — helps change behavior and drive health outcomes. Results of one such program are summarized in Wearables at Work, a technical brief from Vitality, a joint venture of Humana and Discovery Ltd., published April 23, 2014. Vitality has been working in workplace wellness since 2005, first using pedometers to track workers’ workouts. In 2008, Vitality adopted the Polar heart rate monitor for

People are spending more out of their own pockets on health care, and particularly for medications. There are two sides to the medicine-spending coin: there’s the low-end which are generic drugs, most of which carry a co-pay of $10 or less. Then there’s the high end of specialty pharmaceuticals, a fast-growing category of very expensive products for which many consumers dearly pay — if and when they choose to take their doctors’ recommendations. In Medicine use and shifting costs of healthcare, IMS Institute for Healthcare Informatics reports that while (inexpensive) generic drugs comprise 86% of prescriptions in the U.S., it’s high

There’s a new member in the C-suite in health care, and her name is the Chief Patient Officer (CPO). That new role in health-town is filled by Dr. Anne Beal, appointed by Sanofi, the global biopharma company, to fill this new job description. Here she is, shaking hands with Colin Powell in one of the many awards ceremonies where Dr. Beal’s work in public health has been lauded. But what is a CPO? Because it’s a new job, Dr. Beal can create the role, at least within the environment and mission of Sanofi and the larger life sciences world. Some

A consumer who is faced with greater financial skin-in-the-healthcare game, cost-sharing, is expected to become a smart shopper for lower-priced health products and services. When it comes to patients given prescriptions for medicines, the theory is that patients will choose less expensive generic drugs over brand names it people think the cheaper meds are good substitutes. This is referred to as the generic-drug dispensing rate (GDR). But the theory doesn’t consistently hold true in real life, a study from the Employee Benefit Research Institute (EBRI), Brand-Name and Generic Prescription Drug Use After Adoption of a Full-Replacement, Consumer-Directed Health Plan With a

As more U.S. health citizens enroll in high-deductible health plans – now representing about 30% of health-insured people in America – health plan members are being called on to play the role of consumer. Among the most important choices the health consumer makes is for a physician. Ratings sites and health care report cards ranking doctors by various characteristics have been in the market for over a decade. However, little has been known on the public’s knowledge about the availability of these information sources, nor of peoples’ use of physician rating sites. This question is addressed in Public Awareness, Perception, and

This is the first of four posts that are written for the HIMSS 2014 Blog Carnival. The theme, provided by HIMSS (the Healthcare Information and Management Systems Society): “Why Health IT Matters to Consumers.” You’ll note the title here has been purposefully changed. Health IT “should” matter to consumers. Since George Bush declared in 2004 that within 10 years’ time, U.S. health citizens would each have an electronic medical record, there’s been as more bipartisan support inside the Beltway for EHRs than possibly for any other issue in Congress. The American Recovery & Reinvestment Act of 2009 (ARRA), aka the

Millions of health citizens, consumers, patients and caregivers flock to Facebook, Twitter and Wikipedia every day the world over to seek health information, advocate for patients’ access to a cancer therapy on a health blog, engage in peer-to-peer health care in a social network, and bolster each others’ management of chronic medical conditions in a chat community. Yet the pharmaceutical and medical device industries rank well behind other industries vis-à-vis the use of social media, asserts Engaging patients through social media, with the punchline question: is healthcare ready for empowered and digitally demanding patients? from the IMS Institute for Healthcare Informatics, published on

This post appeared in my Huffington Post column on January 16, 2013. In the afterglow of the 2014 Consumer Electronics Show (CES), away from the neon lights of Las Vegas, 4D curved TV screens, and uber-hip Google Glass wearers, a big question remains: Do we, the people, really want to tech our way to self-health? The number of digital health companies exhibiting at CES grew by 40 percent, exceeding 300 based on the count of the International Consumer Electronics Association, sponsor of the event. The hockey-stick growth of “wearable technology” seen at the 2014 Consumer Electronics Show begs the question: Are there

  More than twice as many people value the opinions of friends and family for health care provider choices than turn to online ratings for doctors’ bedside manner, waiting times, or clinical quality, according to the Altarum Institute Survey of Consumer Health Care Opinions, Fall 2013, released on January 8, 2014. 1 in 3 consumers also looks into the cost and quality of services recommended by nurses, doctors, labs and hospitals before choosing a provider. However, most people (4 in 5) say they are comfortable asking their doctor about how much treatment will cost: 43% are “very comfortable,” and 38% somewhat comfortable,

The rise of digital health at the 2014 Consumer Electronics Show signals the hockey-stick growth of consumer-facing health devices for fitness and, increasingly, more medical applications in the hands of people, patients, and caregivers. This year at #CES2014, while the 40% growth of the CES digital health footprint will get the headlines, the underlying story will go beyond wristbands and step-tracking generating data from an N of 1 to tools that generate data to bolster shared-decision making between people and the health system, and eventually support population health. For example: – Aetna is partnering with J&J to deploy their Care4Today

7 in 10 people in the U.S. see a doctor for their health care, and prefer seeing a doctor over a nurse practitioner, based on a poll Ipsos conducted on behalf of the American Academy of Family Physicians. What do people seek in a doctor? Knowledge, state-of-the-art treatments, experience and trustworthiness are the top traits people seek in health providers overall. Ipsos probed further into various traits for clinicians (including doctors, nurses and NPs), asking which of these factors were embodied in the health professional people want to receive care from. The most important attributes for doctors were: Who I want

Who do you trust? If you’re a member of the middle of the U.S. normal bell curve, you’re thinking “nurses.” 8 in 10 Americans put nurses at the top of the ethics list, a question that Gallup has frequently surveyed since 1976. Nurses have ranked highest in honesty and ethics in America since Gallup began included the profession in the poll in 1999 (except for 2001, when firefighters were #1 post 9/11). Tied for second place this year are pharmacists and grade school teachers (with 70% of U.S. adults ranking them with high ethical standards), closely followed by doctors and

While about 53% of people globally are willing to share various types of personal data overall, the kind of data willing-to-be-shared varies by type of information — and what country we’re from. When asked how likely they would be to anonymously share information if it could lead to improvements or innovations in that technology, Americans are less likely to be willing to share any type of personal data — except for gender. When it comes to sharing several specific types of health information, fewer Americans are likely to want to share it as Intel found in their survey published in the company’s Healthcare

23andme received word from the Food & Drug Administration (FDA) on November 22, 2013, that they must cease and desist selling the company’s Saliva Collection Kit and Personal Genome Service (PGS). FDA explained in their Warning Letter, “Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions. “Some of the uses for which PGS is intended are