Is Your Digital Footprint Revealing Private Health Information?

If you use a cell phone, credit cards, websites, search engines, or a medical device, you might be leaving a great deal of private health information (PHI) in your wake, according to a report from the California Healthcare Foundation (CHF). Each day, most of us leave behind a trail of data that can be used to construct a detailed health profile, even if we didn’t intend to give up anything. As health care becomes more intertwined with digital applications, the Internet, and smart phones, new privacy issues are developing as private health information leaks out into the internet. According to the report, the data is incredibly useful and already has served to advance health care in meaningful ways. However, the CHF believes privacy regulations and consumer education need to quickly catch up with the changing health care landscape to address privacy issues that current regulation doesn’t account for.

Data

According to the CHF report, the amount of data related to health care is exploding. In general, consumer data is reaching untold heights; according to the CHF, data is now described in petabytes. A single petabyte is one quadrillion bytes, which the CHF says is enough space to store “the DNA of the entire population of the US, and then clone them twice.” The data exists because consumers are generating it everywhere they go. The CHF gives numerous examples of the sources of data including: web-based diabetes apps, web-based clinical trials, patient social networks, insurance-based wellness program apps, child health monitoring smartphone apps, Wi-Fi heart monitors, search engine queries, and posts to social networking sites. Even the Supreme Court recognized in its recent decision, Riley v. California, that the smart phones many of us carry contain private health care data.

Uses

The mined data has countless applications. The CHF says the information can be used to improve clinical trials, manage diseases, forecast and track epidemics, track data for research purposes, and develop individualized health goals. Going forward, the data can be used to develop personalized medicine that could predict individual health care outcomes. However, the potential usefulness of the data is not without its costs. Although some consumers are willing to give up PHI for the health care benefits, not all individuals are ready to, and even fewer understand the extent to which they are divulging information.

Privacy

The Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) protects private health data. However, HIPAA protections are limited to data held by HIPAA-covered entities. Thus, when data is mined from web-based applications, social networking services, or Internet searches, a consumer cannot be certain that the data is being held by a HIPAA-covered entity. In other words, for much of the data that consumers send out into the expanses of the Internet, current privacy laws are ill equipped to provide any protection.

Where it Goes

The data that consumers unknowingly give up is sometimes sold to third parties. Often times, the data on its face is not health related; however, when pieced together, data about location, age, occupation, exercise interests, income, and weight loss can create a comprehensive picture of an individual’s health. The New York Times reported that some health plans are using this sort of data to engage in predictive health care to anticipate patient claims before they happen. Many patients, however, are unaware of the intimate information hospitals and insurers may access to make their predictions.

Solution

The CHF suggests that new regulations and consumer education can serve as a solution. As technology advances, consumers and regulations need to advance alongside it. When consumers are educated they can make intelligent choices about where and when to divulge PHI. Additionally, regulations can be updated to account for the changing health care landscape and further protect patients from unknowingly losing their health care identities to the Internet.

FDA: Avoid Powdered Pure Caffeine

Powdered caffeine, which is commonly sold over the internet and in other locations should be avoided, according to a Food and Drug Administration (FDA) release. Using ever stronger language, the FDA said the individuals with pre-existing heart conditions should not use the products. The FDA states that these products are almost 100 percent caffeine and even small amounts can be lethal. The FDA stated that it is aware of the death of a teenager in Ohio who consumed one of these products.

Dosage Amounts

The FDA said that consumption of a very small amount of these products can cause an accidental overdose. A single teaspoon of pure caffeine can be the equivalent of 25 cups of coffee. Furthermore, the FDA said that it is nearly impossible to accurately measure powdered caffeine with common kitchen tools. The Washington Post reported in a story on the death of an Ohio teenager that “a mere 1/16th of a teaspoon can contain 200 milligrams of caffeine, roughly the equivalent of two large cups of coffee.”

Symptoms

The symptoms of caffeine overdose include rapid or dangerously erratic heartbeat, seizures, vomiting, stupor, disorientation, and death, according to the FDA. The severity of these symptoms is much greater than simply drinking too much coffee, tea or other caffeinated beverage, said the FDA. An individual who believes they have consumed too much caffeine and are experiencing one of these reactions should seek immediate medical care.

Death of Teenager

A county coroner in Ohio ordered additional tests after a bag with white powder was discovered in the home of an Ohio teenager who unexpectedly died of seizures and an abnormal heart beat. Those tests revealed that the teenager had taken more than a teaspoon of the powder, or about 16 times the recommended dose, according to a report on Cleveland.com. The Washington Post article stated that the same corner’s report said that the teenager “had more than 70 micrograms of caffeine per milliliter of blood in his system, as much as 23 times the amount found in a typical coffee or soda drinker.”

The Substance Abuse and Mental Health Service (SAMHSA) reported that the number of emergency department visits associated with the use of energy drinks has doubled; going from 10,678 in 2007 to 20,783 in 2011. SAMHSA described energy drinks as flavored beverages containing high doses of caffeine. Caffeinated powder, which the FDA is advising people not to use and the cause of the death of the teenager in Ohio, is sold as a dietary supplement and as such is not as heavily regulated as other substances. Users routinely added it to drinks as a way of weight control.

The FDA would like people to report adverse events associated with the use of powdered caffeine by calling them at 240-402-2405 or by email at CAERS@cfsan.fda.gov.

FedEx Indicted for Distributing Illegal Internet Pharmacy Drugs

The U.S. Attorney for the Northern District of California has indicted the FedEx Corporation, FedExExpress, Inc. and FedEx Corporate Services, Inc. (collectively, FedEx) for conspiring with two separate—but related— online Internet pharmacy organizations, the Chhabra-Smoley Organization and Superior Drugs, to distribute controlled substances and prescription drugs to U.S. consumers who had no legitimate medical need for them based on invalid prescriptions.

Background

Since 1998, when Internet pharmacies first began offering consumers prescription drugs, some of these pharmacies have been filling orders based only on the completion of an online questionnaire, without a physical examination, a proper diagnosis, or a face-to-face meeting with a physician. This practice violates both federal and state laws governing the distribution of prescription drugs and controlled substances.

Warnings Made to FedEx

According to the indictment, as early as 2004, FedEx had been warned by the FDA, the Drug Enforcement Administration (DEA), and Congressional members and their staff that illegal Internet pharmacies where using FedEx services to distribute prescription drugs and controlled substances in violation of the FDC Act, the Controlled Substances Act (CSA), and other state laws.

Knowledge of Illegality Alleged

The indictment also alleges that in response to these warnings, FedEx established an Online Pharmacy Credit Policy requiring that all online pharmacy shippers be approved by the Credit Department prior to opening a new account. FedEx purportedly established a Sales policy in which all online pharmacies were assigned to a “catchall” classification to protect the commission-based compensation of its sales professionals from the volatility caused by online pharmacies moving shipping locations often to avoid DEA detection.

The indictment further alleges that, as early as 2004, FedEx clearly knew that it was delivering drugs to dealers and addicts because FedEx’s couriers expressed safety concerns to management that FedEx trucks were stopped on the road by online pharmacy customers demanding drugs, that the delivery address was a parking lot, school, or vacant home, and that FedEx drivers were threatened if they insisted on delivering packages to an address instead of giving the packages to individuals who demanded them. In response, the indictment alleges that FedEx merely held Internet pharmacy packages for problem shippers for pick up at specific stations, rather than delivering them.

FedEx’s employees are also alleged to have known that the Chhabra-Smoley and Superior Drugs online pharmacies had been shut down, and that their owners, operators, pharmacists, and doctors had been indicted, arrested, and convicted of illegally distributing drugs. Nevertheless, FedEx allegedly continued to deliver controlled substances and prescription drugs for these organizations.

Specific Statutory Violations

The indictment specifically charges FedEx with knowingly and intentionally conspiring with the Chhabra-Smoley Organization (from 2000 through 2008) and Superior Drugs (from 2002 through 2010) to violate the CSA, 21 U.S.C. Secs. 841 and 846, and the FDC Act, 21 U.S.C. Secs. 331, et seq., by distributing controlled substances and prescription drugs, including Phendimetrazine (Schedule III); Ambien, Phentermine, Diazepam, and Alprazolam (Schedule IV), to customers who had no legitimate medical need for them based on invalid prescriptions.

FedEx must appear in federal court in San Francisco on July 29, 2014, to answer the charges.

Mobile Health Apps Bridge Doctor-Patient Divide

Among the top-rated iPhone and Android apps, according to healthline.com, are programs that allow users to track the distance they walked or biked for the day, keep a personalized log of prescription drugs and relevant medical information, record recurring symptoms, and even monitor their sleep cycles, so a programmed alarm clock will go off when the users are at their lightest sleep period and ready to be awakened. Recent reports have indicated that these apps are not just being used by consumers, but are also being touted by physicians as tools used in patient treatment. As the “convergence of medical and consumer apps” becomes more apparent, newer, more highly-functioning apps are expected, yet, will those apps overload our collective hard drive and prove to be more hassle than helpful?

Convergence

A techonomy.com article explored the notion of the converging paths of medical and consumer health apps, stating that recent reports have shown that, “in the future, experts see the integration of consumer apps and devices into ‘a comprehensive healthcare and wellness information system,’ that could enable medical professional to help patients manage their health…” Specifically, the piece mentions the use of mobile apps at the cardiac rehabilitation program at the Mayo Clinic of evidence that, as one expert stated, “physicians are embracing the trend.” Additionally, four large app-building projects are underway at the Center for Digital Health Innovation at the University of California, San Francisco that would, if turned into products, be available to consumers to collaborate with physicians on health issues.

Recipe for Disaster?

While some are optimistic about the future of professional- and consumer-based usage of apps, others have raised questions about the future mobile app industry’s propensity for unwieldiness. In particular, an expert opined that the massive amounts and breadth of data that could be collected by these apps could present a regulatory nightmare while another claimed that “too much data could stifle physician productivity.”

On the Horizon

Regardless of the potential issues raised by the merging of mobile apps for consumers and physicians, it appears that innovation is already pointing in that direction, as one analysis finds that health care management apps are following in the footsteps of (and working in conjunction with) wearable fitness tracking devices. The report acknowledges certain apps that are “worth a look” including: Samsung S Health, which allows the consumer to track nutrition, fitness, and wellness; WebMD Healthy Target, which was designed as a tool for diabetics, hypoglycemic individuals, and those struggling with obesity to monitor weight and blood sugar; and Apple Health, which “displays personal biometric data- heart rate, calories consumers and burned, blood sugar and cholesterol – from the fitness apps that actually collect the data and from devices such as JawBone and IBGStar Blood Glucose Meter.”

An article published on the online Business Insider, however, states that while the new innovations in health care apps are popular, they are not necessarily effective. That source refers to a 2013 report issued by the IMS Institute for Healthcare Informatics that found “most consumer-oriented health apps are severely lacking when it comes to functionality or what they actually allow users to do.” Indeed, “…increased usage doesn’t necessarily correlate with quality.” Specifically, the author of this piece points out that while these health care supporting apps are plentiful, their functionality is limited. In turn, the source predicts, the real revolution is not in the convergence of consumer and medical professional usage of health apps but in the merging of wearable trackers that also function, as apps do, to compile and analyze tracked data. “The real killer app probably won’t be an app at all. It will be whatever device successfully combines the limited functionality that so many apps have into an integrated platform that can actually change people’s health and habits in a holistic way.”

This proposition begs the question, will these combined function devices take over the health care app game? If so, will these devices face similar regulatory and data administration and use challenges that health care apps potentially face? Regardless of the direction of this industry, the bridge between patient care by medical professionals, consumerism, and technology has been forged and consideration of its implications must be undertaken in order to cross it.