Introduction
As technology advances, medical devices are able to record increasing amounts of information. These devices are also becoming much more assessable to consumers than in the past. In Adam Tanner’s article “Health Entrepreneur Debates Going To Data’s Dark Side,” he discusses the company Safe Heart. Safe Heart is developing medical devices for consumer use. These devices are able to measure values like blood oxygen saturation, heart rate, and perfusion index. Being able to collect these massive amounts of data, places these devices in the realm of big data. Although the topic of big data imposes its own issues, the medical nature of the data creates an additional set of important issues.
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Safe Heart is not the first organization to develop devices that collect “big” quantities of data. In recent years, many organizations have begun to capture and use large quantities of medical data. Hospitals, credit agencies and researchers have all started to use medical data to the advantage of either the patient or their own corporation. With all the data being captured, there are legal and ethical issues that become apparent.
Main Issues
The most prominent issue related to big healthcare technology data is a legal one. The Health Insurance Portability and Accountability Act (HIPAA), protects health data that is transmitted by a certain groups and organizations [1]. It states that consent must be obtained from the patient to distribute any information to a third party. The organizations included are health plans, health care clearinghouses, and some health care providers [1]. This would mean that non-health organizations transmitting health information would not be subject to HIPAA. The previously mentioned organization Safe Heart, would not be subject to HIPAA because they are not an organization covered by the act. Safe Heart would be able to transmit data in a variety of ways and not be limited by the restrictions of HIPAA. Another act that has the power to govern patient data, but is not optimized for current technologies, is the Privacy Act [1]. The Privacy Act protects data that is distributed by the federal government. To distribute data, the government must remove personally identifying information from the records [1]. After the information is removed, this allows the government to distribute massive amounts of civilian health data publically. As long as explicitly identifying attributes like name and address have been removed, the Privacy Act does not limit how much, or where the data can be distributed. There are few bounds on what the government can do, making this a pressing legal issue.
Big data also imposes several ethical issues on healthcare technology. Even though health agencies may anonymize data in accordance with the Privacy Act, it is still possible to associate the data back to the individual. The Massachusetts Group Insurance Commission released a dataset in the 1990s, and they assured the public that the data had been completely anonymized. A graduate student at the time combined this dataset with voting data and was able to associate medical data back to the correct patient. Shortly after this, it was shown that an American can be identified with only their zip code, birthdate and sex [2]. This imposes a myriad of issues on medical technology companies like Safe Heart. If a released dataset is not properly anonymized, the large amounts of data collected by the devices can be associated back to the patients. This also has powerful ethical implications when considering the results of a study done by the Privacy Rights Clearinghouse. This organization studied a collection of mobile health and fitness applications for both iOS and Android operating systems. The study found that many of the applications transmitted data, without user notification, to third parties. The data transmitted included items like latitude, longitude, and zip code data [3]. Since many of the developers were not medical entities, the data sharing is not limited. The medical data can be used for marketing of products and can be sold to third parties for other uses. This is a large invasion of user privacy and creates one more way to link consumers to their already existing medical data that has been “anonymized.”
Major Stakeholders
The winners here are largely marketing and advertising agencies. After buying a, or using a publically available, dataset marketers can use the few remaining pieces of identifying information like location, age and gender to target specific consumers. With improved consumer targeting, marketing and advertising agencies can increase their revenue and further their own product line. The consumers are also winners depending on how their data is handled. If the data is handled correctly, the profits from the distribution of the data would allow companies, like SafeHeart, to subsidize the cost of the medical devices [4]. Subsidized devices would allow medical technological companies to reach a broader demographic, providing increased public benefit. The data gathered by the consumer medical devices can also be used to enhance medical research providing additional benefit to the consumers [5]. Finally, the collection of data can benefit consumers because it enables improved tracking of diseases among an entire population [6]. If diseases can be detected faster, a large portion of the public would benefit.
Although consumers can reap a large number of benefits from big data in healthcare, they are losers as well. There will be many consumers who do not want their data to be affiliated with marketing or advertising agencies. To these consumers, this is viewed as an extreme invasion of privacy. In addition to the undesired sharing, these users may be subject to the re-identification process. Even though the shared medical data contains few identifying attributes, the remaining information can be used to associate the original consumer with the appropriate medical record [2]. This too in an invasion of the consumer’s privacy, contrary to many of their desires. After consumers, some medical technology entities are also losers. For companies like Safe Heart, the profit from released datasets would reduce costs to the consumer. As a medical company, improving the public’s health is one of their primary missions. The potential that consumers may be re-identified, or targeted by marketing, with the data discourages release. The apprehension to release data limits data available to researchers making them losers as well. If data were released, researchers would be able to expedite research and provide solutions to prevalent health problems [5]. Consumers may resent the release of their data, but those trying to benefit them can produce worthwhile returns.
Summary
Advances in healthcare technology have also given birth to an increase in the amount of big data created by medical devices. Medical big data creates a unique set of legal and ethical issues that companies like Safe Heart must, and are, considering. Legally, acts like HIPAA and the Privacy Act do not sufficiently protect the data of patients. Data can move considerably freely and it is not always transferred in a completely anonymous state. It has been shown that organizations are not handling the data in an ethical manner. The release and negligent handling of the data completely invades the privacy of the patient. For marketers, this aids when trying to increase revenue. Due to many of these issues, companies have started to limit what data they share when medical devices generate it. Without accessible data sets, progress of researchers is slowed and the standard of care for the public falls. Both the benefits and risks must be considered when medical big data is involved.
Conclusions
Health devices transmitting big data are already involved in our lives. It is a serious legal issue that HIPAA and the Privacy Act do not govern our health data properly. It is critical that our laws catch up with this rapidly developing technology. A reasonable person may argue that health data should be completely restricted and there should be no transmission, or distribution, at all. It is true that data laws need to be revisited and improved, but complete restriction would be an extreme waste of the potential that medical big data stores. After the laws have been optimized for the technology, the data has the ability to improve health care throughout the nation. Big data can be extremely useful for entities like hospitals. Using patient data, hospitals can monitor a patient’s condition and know more quickly when they are due to worsen [7]. Advanced algorithms can also predict and help to prevent conditions like renal failure, infections, and negative reactions to drugs [7]. When physicians are combined with big data indicators, more patients can be helped and conditions can be monitored more reliably than in the past. In conclusion, I think that big data in healthcare should be embraced, but not before we strengthen the laws governing it.
References
[1] Kalyvas, James R. and Overly, Michael R. Big Data: A Business and Legal Guide. Auerbach Publications. 55-58.
[2] Anderson, Nate. “Anonymized” data really isn’t—and here’s why not. 9/8/09. http://arstechnica.com/tech-policy/2009/09/your-secrets-live-online-in-databases-of-ruin/
[3] Njie, Craig Michael Lie. Technical Analysis of the Data Practices and Privacy Risks of 43 Popular Mobile Health and Fitness Applications. 7/15/2013 http://www.privacyrights.org/mobile-medical-apps-privacy-technologist-research-report.pdf.
[4] Tanner, Adam. Health Entrepreneur Debates Going To Data’s Dark Side. 9/16/14 http://www.forbes.com/sites/adamtanner/2014/09/16/health-entrepreneur-debates-going-to-datas-dark-side/
[5] Standen, Amy. How Big Data Is Changing Medicine. 9/29/14. http://blogs.kqed.org/science/audio/how-big-data-is-changing-medicine/
[6] Schmarzo, Bill. Big Data Technologies and Advancements in Healthcare. 3/25/14. https://infocus.emc.com/william_schmarzo/big-data-technologies-and-advancements-in-healthcare/
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