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A Closer Look at Data-Driven Health Care

Industry resources, upcoming events, companies to watch, and a primer on reimbursement.

-Computing hardware and software
-A new health app will be built into Apple’s next-generation operating system
-Vital statistic: 150.3 million iPhones were sold in 2013, for $91 billion in revenue

There are already tens of thousands of third-party fitness and health applications for the iPhone, but in June, Apple executives revealed that the company would be launching one of its own. As part of the new iOS8 operating system, a new app called Health will give users a comprehensive view of vital signs—including blood pressure—plus weight, activity, and diet. Some data will be gathered from monitors that users wear and some recorded by them manually. Apple also plans to release a developer tool called HealthKit that will enable Health users to share these statistics with existing applications, like Nike’s fitness tracker and the Mayo Clinic app. The hope is that this will improve the apps’ performance and offer potential benefits ranging from an improved workout to automatic doctor calls at signs of danger.

Epic Systems
-Electronic records
-Makes the software health-care organizations and hospitals use to manage electronic records
-Vital statistic: 100 million patients’ records are accessible to companies using Epic’s health information exchange, Care Everywhere

Privately held Epic Systems provides electronic medical records and software to 315 hospitals and health-care providers, including the Cleveland Clinic, the Dartmouth-Hitchcock Medical Center, and several Kaiser Permanente health plans, and has been a major beneficiary of a federal program reimbursing health-care providers for adopting digital record-keeping. Next, Epic has its eye on the Department of Defense, and it’s teaming up with IBM to compete for a contract covering more than 9.7 million people. Apple’s new Health app will be able to add data to MyChart, Epic’s mobile tool for patients, with which they can view test results, schedule appointments, pay bills, and send messages to health-care providers.

-Web search giant
-A new Android app platform is Google’s second attempt at building a health business
-Vital statistic: There are more than 40,000 health apps available for Android phones, but only a handful have been downloaded by more than 500 users

In June, Google joined Apple in launching Google Fit, a new developer platform for fitness-tracking apps. Sensors on mobile and wearable devices—including Google’s new smart watch and Android phones, but also items from other manufacturers, like the Withings smart scale—would help users track their data. The company’s first foray into health care, Google Health, a digital health record analogous to Microsoft’s HealthVault, was discontinued in January 2012. The company said that it “didn’t catch on the way we would have hoped.”

-Genome sequencing
-Sells genome-sequencing machines and tools for analyzing the data
-Vital statistic: $1.42 billion in fiscal 2013 revenue

Illumina was at the top of the list of MIT Technology Review’s smartest companies earlier this year after its CEO, Jay Flatley, announced that the firm had hit a long-held goal—sequencing a human genome for $1,000, a price seen as low enough for widespread use in a clinical context. The MyGenome iPad app enables doctors and patients alike to visualize genome data, highlighting genetic variants and predicting how they may affect health. “One of the biggest challenges now is increasing the clinical knowledge of what the genome means,” Flatley told MIT Technology Review late last year. Illumina, he said, intends to be “at the apex of that effort.”

Merck Global Health Innovation Fund
-Venture capitalarm of pharmaceutical maker
-Invests in new digital health technologies
-Vital statistic: $500 million has been invested in more than 20 companies

One way drug giant Merck stays abreast of new technology is by investing in digital health-care startups through its venture capital fund. Investments focus on remote monitoring, data analysis, and personalized medicine. They include ElectroCore, a company developing technology to treat headaches with electrical signals; Preventice, the creator of an FDA-approved patient monitoring system that tracks biometrics like heart rate through a wearable sensor; and GenomeDX, which develops genomic tests for prostate and urological cancers.

-Computing hardware and software
-Markets tablets and cloud-based software tools to health-care providers
-Vital statistic: $77.8 billion in fiscal 2013 revenue

Microsoft has been dabbling in health records since at least 2007, when it launched software called HealthVault to manage medical records. Now adapted to smartphones, it connects to third-party apps from Aetna, the American Diabetes Association, and others that allow users to manage prescription information and track fitness statistics. The software giant has not shared how many people are using the service, which is free, but it does not seem to be a major part of Microsoft’s business; HealthVault has nearly 9,700 followers on Twitter and 5,300 on Facebook. Health-care companies are also using Microsoft’s products to collect digital health data such as electronic clinical questionnaires.

-Diversified technology company
-In-home monitors and other devices connect patient to physician
-Vital statistic: In 2013 health-care sales were 9.6 billion euros, 41 percent of the company’s total. Its home health care and informatics businesses grew modestly.

Philips already makes monitors that enable doctors to monitor heart patients at home and informatics programs to help care providers evaluate data. That’s just part of its sizable health-care business. Facing the possibility that some of these functions could move to mobile phones, the firm is expanding the focus of its “Hospital to Home” program and creating health sensors for wearable devices. In June it announced a collaboration with cloud computing company to launch a secure platform that would connect data from personal and wearable devices with clinical data like labs and medical records.

Qualcomm Life
-Qualcomm subsidiary focused on wireless health technologies
-Sells wireless health monitoring systems and services to health-care providers
-Vital statistic: more than 400 health-care companies use a Qualcomm-supported wireless tracking “ecosystem” to connect health data with doctors, patients, and payers

Qualcomm Life technology sends data wirelessly from medical devices to the cloud through a connectivity gateway called the 2Net Hub. This new technology, unveiled last September, allows patients to use their Android smartphones to transmit information gathered from devices like blood glucose meters, weight scales, blood pressure cuffs, and pulse oximeters. The phones connect to the medical devices via software built in with the help of a developers’ kit.

Samsung Electronics
-Electronics manufacturer
-Makes electronics products aimed at tracking activity and fitness
-Vital statistic: Top smartphone manufacturer, with 31 percent of the market in 2013

Days before rival Apple unveiled its health monitoring application, Samsung shared its latest vision for health tracking: a wearable device called the Simband that tracks real-time information like temperature and heart rate and can share that information with cloud-based applications. Meanwhile, Samsung has partnered with the University of California San Francisco to open a new lab dedicated to testing and validating these gadgets.

-Data analysis
-Makes software tools to help health-care providers lower costs and interpret data
-Vital statistic: Privately held, $3.02 billion in revenue

As more hospitals adopt electronic health records, spending on tools to analyze that data is expected to increase. Last year, 59 percent of U.S. hospitals were using a basic electronic-health-record system, up from just 9.4 percent in 2008. SAS makes analytic tools that allow hospitals to visualize information about issues like how health-care costs are distributed across regions and how chronic illnesses affect health-care costs. Beyond assessing costs, SAS is now looking for ways to help improve health-care quality, such as a program recently implemented with a large pharmaceutical company that provides a secure way for researchers to access data from clinical trials.

U.S. National Center for Telehealth and Technology
-Government organization
-Vital statistic: Operating budget of $28.3 million in fiscal 2013; established in 2008

In 2012, 250,000 former members of the U.S. military were diagnosed with post-traumatic stress disorder (PTSD). One app created by the center, the PTSD Coach, has been downloaded more than 100,000 times and is the subject of a randomized controlled research study at Stanford University to evaluate its long-term efficacy. The BioZen app uses brainwaves, respiratory rate, skin temperature, and electrocardiogram data, all captured by sensors the user wears, to calculate a relaxation level that can be displayed on a smartphone. The information is transmitted wirelessly to an Android device.

-Provides IT and telehealth products for health-care companies
-Vital statistic: $120.6 billion in revenues

As a carrier, Verizon benefits if more data travels over mobile phones, and it’s promoting mobile health through a number of programs. Verizon Virtual Visits allows patients to remotely consult clinicians by smartphone, and clinicians can electronically file prescriptions at a patient’s local pharmacy when needed. Verizon also has FDA approval for a platform known as Converged Health Management, which runs on Apple’s iOS operating system and allows clinicians to remotely monitor patient information like blood glucose levels and weight through several different devices. Verizon has not announced any customers for the system yet but confirms that it is undergoing one clinical trial.

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David Lazer et al., “The Parable of Google Flu: Traps in Big Data Analysis,” Science, March 2014
When Google launched Flu Trends in 2008, hopes were high that the company would use its algorithmic magic to save lives by analyzing the search terms of millions of users worldwide to track the progress of flu strains in real time. A widely publicized 2013 study revealed, however, that Google greatly overestimated the prevalence of flu cases during the 2011–2012 season. In an article published earlier this year in Science, four social scientists reveal that this was not an isolated failure. They argue that Google’s approach provides a cautionary tale of “Big Data hubris.”

Using Big Data to Transform Care,” Health Affairs, July 2014
Exploring the connections between big data and policy, the journal taps top academic experts for insight into how data is changing health care. Several pieces look at predictive analytic tools that could help doctors give better care; others cover patient-powered research networks and the policy challenges of genomics.

Alberto Gutierrez, “Food and Drug Administration Warning Letter,” November 2013
Last fall, the FDA addressed an uncharacteristically scathing letter to Anne Wojcicki, CEO of the genetic testing company 23andMe, ordering the company to stop selling its “personal genome service” because of concerns that the information it was providing to customers was not clinically validated. The letter specifically mentioned 23andMe’s screens for cancer-associated mutations and genetic drug sensitivities, citing “the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.” The Google-funded company’s effort to bring personalized genomics into the mainstream is at a standstill while it seeks resolution of the regulatory impasse.

Peter Groves et al., “The ‘Big Data’ Revolution in Healthcare: Accelerating Value and Innovation,” McKinsey & Company, January 2013
In this white paper, McKinsey consultants make the case that after years of effort and billions of dollars spent digitizing, organizing, and networking patient health records, the industry is now at a tipping point: new tools, apps, and devices will help providers and patients make use of this data to improve care and lower costs. The authors estimate that if certain proven technologies were instituted system-wide, the U.S. could see a $300 billion to $450 billion reduction in annual health-care spending, but they caution that significant industry inertia must be overcome.

Francis S. Collins, The Language of Life: DNA and the Revolution in Personalized Medicine, Harper Perennial, 2011
The former head of the Human Genome Project and current director of the National Institutes of Health makes the case that the genomics revolution will lead to a new era of medicine optimized for each patient’s genetic heritage. Collins opens the book on a personal note, explaining how he helped his family make use of discoveries about the genetic basis for diseases such as breast cancer and Charcot-Marie-Tooth disease to access genetic testing, quantify their risk, and ultimately guide their health-care decisions. Increasingly, he argues, DNA will unlock the secrets of the 6,000 known rare diseases as well as common ailments like heart disease and asthma. His early research found genetic factors in diseases including type 2 diabetes and cystic fibrosis.

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Too Much Information,” January/February 2014
With a number of companies marketing noninvasive genetic tests that promise to identify abnormalities early in a pregnancy, Amanda Schaffer looked at how expecting parents and their doctors will make sense of this newly available data and the thorny ethical issues surrounding it.

A Hospital Takes Its Own Big-Data Medicine,” November/December 2013
As part of last year’s Business Report on rising health-care costs, Courtney Humphries described how one major research hospital bet on big data: by investing in supercomputing and recruiting Facebook’s chief data scientist to help analyze the vast amount of information doctors collect.

Bases to Bytes,” May/June 2012
Research editor Mike Orcutt put the genomic revolution into visual focus with a series of charts illustrating how the plummeting cost of DNA sequencing has led to an exponential increase in the number of full genomes sequenced. If the trend continues, it may test the limits of our ability to store data.

The Patient of the Future,” March/April 2012
In a big-data detective story, Jon Cohen recounted how computer pioneer Larry Smarr used wearable sensors to gather a wealth of data about himself, which he then analyzed to help doctors diagnose his Crohn’s disease. The process reflects how tech-savvy individuals are using data analytics to take control of their own health and treatment.

Kenya’s Startup Boom,” March/April 2012
When chief correspondent David Talbot paid a visit to Nairobi, a hotbed of the mobile health movement sweeping Africa, he met an inspiring group of young programmers developing phone-based tools that could allow social workers and the patients they serve to access health information, communicate with doctors, and report disease outbreaks to health authorities.

Prescription: Networking,” November/December 2009
The data doctors collect from patients is of little use if it can’t be instantly accessed wherever care is provided, so chief correspondent David Talbot took readers on a tour of hospitals and community health centers in one city to show how they were attempting to build a network to exchange this information.

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Who decides if a treatment is worth the price? Once that was the domain of insurance companies and Medicare, but today the answer is more complicated. More than one-third of Americans today have high-deductible insurance plans and must cover medical costs up to $1,250 per year themselves ($2,500 if family is covered as well), creating a new category of price-conscious health-care consumers. The Affordable Care Act’s promotion of accountable care organizations, which are paid a certain amount per patient no matter how much care they require, means more caregivers will now be the ones making those cost decisions.

Traditional insurance and government programs remain the most common way for Americans to pay for health care, and the pace at which data-driven medicine is adopted will be decided by the extent to which these programs reimburse genetic testing or mobile health devices.

A study performed by UnitedHealthcare in 2012 determined that the company had spent $500 million on genetic and molecular tests in 2010, of a total $5 billion spent nationally, and predicted that by 2021, spending on these tests nationwide could reach $15 billion to $25 billion. Yet insurance companies remain skeptical about the health benefits of many genetic tests.

Here is what is being paid for today, according to interviews with genetic counselors, hospital administrators, pharmacy advisory firms, academic studies, and consulting reports.

Genomics and Gene Testing

Sequencing a human genome has dropped in cost significantly, but the price remains high at $3,500 or so—up to five times that when interpretation of the results is added. Only about half of insurance submissions are approved. Reimbursement is most likely when the cost of the other tests that would have to be done for diagnosis outweigh the cost of sequencing. Illumina, the leading sequencer, does not bill insurance.

Sequencing the exome, the subset of the human genome that includes all the body’s important instructions for building proteins, has reimbursement rates comparable to those for established genetic tests. In one recent study, 98 percent of submissions were approved.

Targeted genetic testing for rare diseases and hereditary cancers, like colorectal and breast cancers associated with certain mutations of the BRCA1 or BRCA2 gene, is generally covered when family history or other factors indicate a risk. The specific amount varies. In January, Medicare reimbursement for the BRCA1 and BRCA2 tests dropped from nearly $3,000 to a maximum of $1,440 after competition among testing firms picked up. Screening expectant parents to see if they carry genes for conditions like cystic fibrosis is generally covered, as is testing fetuses for Down syndrome.

Multigene panel testing has been broadly available for just over a year, following a Supreme Court ruling that opened up testing for some mutations by suggesting that genes can no longer be patented. The test is often covered by insurance, but genetic counselors report that coverage is increasingly being denied on the basis of cost and a preference for less expensive single-gene testing, though early studies have shown that multigene hereditary-cancer panels have benefits over the cheaper tests.

Pharmacogenetic testing, which provides information about how well a patient is likely to respond to a given medication, is beginning to be covered. Pharmacy benefits manager Express Scripts has established about 20 tests for which the evidence supports reimbursement.

Mobile Health

The FDA is regulating diagnostic apps and accessories that turn a mobile phone into a medical device like an electrocardiogram or blood pressure monitor. More than two dozen apps and devices are FDA approved and eligible for insurance reimbursement. Still, insurance companies deem many of these items “experimental and investigational” and hold that their clinical value is not yet established, so they will not cover their costs.

A limited number of insurers pay for activity-tracking mobile devices and apps. Nearly one-third pay for the cost of mobile communications to patients about drug adherence and other health-related issues, according to a study performed by the Economist Intelligence Unit for the consulting and accounting firm PWC. According to that same study, 29 percent are paying for medical professionals to receive mobile data as a tool for patient monitoring, and 30 percent cover practitioners’ analysis of health and wellness data gathered by mobile devices.

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July 22–24, 2014
The 2nd International Conference on Big Data and Analytics in Healthcare, Singapore

October 6–7, 2014
Predictive Analytics World Healthcare 1st Annual Conference, Boston

October 10–11, 2014
5th Annual Workshop on Health IT & Economics, Washington, D.C.

October 22–23, 2014
Data 360 Conference, Santa Clara, California

November 4–5, 2014
Big Data & Analytics for Pharma Summit, Philadelphia

January 26–28, 2015
Personalized Medicine World Congress, Mountain View, California

January 26–29, 2015
Arab Health Congress, Dubai

February 24–25, 2015
World BioPharma Big Data Congress, London

May 20–22, 2015
Big Data in Biomedicine Conference, Palo Alto, California

May 31–June 3, 2015
Health Datapalooza, Washington, D.C.

August 12–13, 2015
National Forum on Data & Analytics, Washington, D.C.

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