United States: The White House Big Data Report & Apple’s iOS 8: Shining The Light On An Alternative Approach To Privacy And Biomedical Research

Last Updated: June 10 2014
Article by Jeremiah J. Posedel

Introduction

Big data derives from "the growing technological ability to capture, aggregate, and process an ever-greater volume, velocity, and variety of data."1 Apple's just-released iOS 8 software development kit ("iOS 8 SDK") highlights this growth.2 The iOS 8 SDK touts over 4,000 application programming interface calls including "greater extensibility" and "new frameworks."3 For example, HomeKit and HealthKit, two of these new frameworks, serve as hubs for data generated by other applications and provide user interfaces to manage that data and related functionality.4 HealthKit's APIs "provide the ability for health and fitness apps to communicate with each other ... to provide a more comprehensive way to manage your health and fitness."5 HomeKit integrates home automation functions in a central location within the iOS device, allowing users to lock/unlock doors, turn on/off cameras, change or view thermostat settings, turn lights on/off, open garage doors and more – all from a single app.6 The iOS 8 SDK will inevitably lead to the development of countless apps and other technologies that "capture, aggregate, and process an ever-greater volume, velocity, and variety of data," contributing immense volumes of data to the already-gargantuan big data ecosystem.

In the context of our health and wellbeing, big data – which includes, but is definitely not limited to, data generated by future iOS 8-related technologies – has boundless potential and can have a momentous impact on biomedical research, leading to new therapies and improved health outcomes. The big data reports recently issued by the White House and the President's Council of Advisors on Science and Technology ("PCAST") echo this fact. However, these reports also emphasize the challenges posed by applying the current approach to privacy to big data, including the focus on notice and consent.

After providing some background, this article examines the impact of big data on medical research. It then explores the privacy challenges posed by focusing on notice and consent with respect to big data. Finally, this article describes an alternative approach to privacy suggested by the big data reports and its application to biomedical research.

Background

On May 1, 2014, the White House released its report on big data, "Big Data: Seizing Opportunities, Preserving Values" ("WH Report"). The WH Report was supported by a separate effort and report produced by PCAST, "Big Data and Privacy: A Technological Perspective" ("PCAST Report").7 The privacy implications of the eports on biomedical research – an area where big data can arguably have the greatest impact – are significant.

Notice and consent provide the foundation upon which privacy laws are built. Accordingly, it can be difficult to envision a situation where these conceptual underpinnings, while still important, begin to yield to a new approach. However, that is exactly what the reports suggest in the context of big data. As HealthKit and iOS 8 SDK demonstrate, we live in a world where health data is generated in numerous ways, both inside and outside of the traditional patient-doctor relationship. If given access to all this data, researchers can better analyze the effectiveness of existing therapies, develop new therapies faster, and more accurately predict and suggest measures to avoid the onset of disease, all leading to improved health outcomes. However, existing privacy laws often restrict researchers' access to such data without first soliciting and obtaining proof of appropriate notice and consent.8 Focusing on individual notice and consent in some instances can be unnecessarily restrictive and can stall the discovery and development of new therapies. This is exacerbated by the fact that de-identification (or pseudonymization) – a process typically relied upon to alleviate some of these obstacles – is losing its effectiveness or would require stripping data of much meaningful value. Recognizing these flaws, the WH Report suggests a new approach where the focus is taken off of the collection of data and turned to the ways in which parties, including biomedical researchers, use data – an approach that allows researchers to maximize the possibilities of big data, while protecting individual privacy and ensuring that data is processed in a reasonable way.

The Benefits of Big Data to Biomedical Research

Before discussing why a new approach to privacy in the context of big data and biomedical research may be necessary, it is first important to understand the role of big data in research. As noted, the concept of big data encompasses "the growing technological ability to capture, aggregate, and process an ever-greater volume, velocity, and variety of data."9 The word "growing" is essential here, as the sources of data contributing to the big data ecosystem are extensive and will continue to expand, especially as Internet-enabled devices such as those contemplated by HomeKit continue to develop.10 These sources include not only the traditional doctor-patient relationship, but also consumer-generated and other non-traditional sources of health data such as those contemplated by HealthKit, including wearable technologies (e.g., Fitbit), patient-support sites (e.g., PatientsLikeMe.com), wellness programs, electronic/personal health records, etc. These sources expand even further when non-health data is combined with lifestyle and financial data.11

The WH Report recognizes that these new abilities to collect and process information have the potential to bring about "unexpected ... advancements in our quality of life."12 The ability of researchers to analyze this vast amount of data can help "identify clinical treatments, prescription drugs, and public health interventions that may not appear to be effective in smaller samples, across broad populations, or using traditional research methods."13 In some instances, big data can in fact be the necessary component of a life-changing discovery.14

Further, the WH Report finds that big data holds the key to fully realizing the promise of predictive medicine, whereby doctors and researchers can fully analyze an individual's health status and genetic information to better predict the onset of disease and/or how an individual might respond to specific therapies.15 These findings have the ability to affect not only particular patients but also family members and others with a similar genetic makeup.16 It is worth noting that the WH Report highlights bio-banks and their role in "confronting important questions about personal privacy in the context of health research and treatment."17

In summary, big data has a profound impact on biomedical research and, as a necessary result, on those that benefit from the fruits of researchers' labor. The key to its realization is a privacy regime that can unlock for researchers vast amounts of different types of data obtained from diverse sources.

Problems With the Current Approach

Where the use of information is not directly regulated by the existing privacy framework, providing consumers with notice and choice regarding the processing of their personal information has become the de facto rule. Where the collection and use of information is specifically regulated (e.g., HIPAA, FCRA, etc.), notice and consent is required whenever information is used or shared in a way not permitted under the relevant statute. For example, under HIPAA, a doctor can disclose a patient's personal health information for treatment purposes (permissible use) but would need to provide the patient with notice and obtain consent before disclosing the same information for marketing purposes (impermissible use). To avoid this obligation, entities seeking to share data in a way not described in the privacy notice and/or permitted under applicable law can de-identify the data, to purportedly make the data anonymous (for example, John Smith drives a white Honda and makes $55,000/year (identified) v. Person X drives a white Honda and makes $55,000/year (de-identified)).18 Except under very limited circumstances (e.g., HIPAA limited data sets), the requirements regarding notice and consent apply equally to biomedical research as to more commercial uses.

In the context of big data, the first problem with notice and consent is that it places an enormous burden on the individual to manage all of the relevant privacy notices applicable to the processing of that individual's data. In other words, it requires individuals to analyze each and every privacy notice applicable to them (which could be hundreds, if not more), determine whether those data collectors share information and with whom, and then attempt to track that information down as necessary. As the PCAST Report not-so-delicately states, "[i]n some fantasy world, users actually read these notices, understand their legal implications (consulting their attorneys if necessary), negotiate with other providers of similar services to get better privacy treatment, and only then click to indicate their consent. Reality is different."19 This is aggravated by the fact that relevant privacy terms are often buried in privacy notices using legalese and provided on a take-it-or-leave-it basis.20 Although notice and consent may still play an important role where there is a direct connection between data collectors and individuals, it is evident why such a model loses its meaning when information is collected from a number of varied sources and those analyzing the data have no direct relationship with individuals.

Second, even where specific privacy regulations apply to the collection and use of personal information, such rules rarely consider or routinely allow for the disclosure of that information to researchers for biomedical research purposes, thus requiring researchers to independently provide notice and obtain consent. As the WH Report points out, "[t]he privacy frameworks that currently cover information now used in health may not be well suited to ... facilitate the research that drives them."21 And as previously noted, often times biomedical researchers require non-health information, including lifestyle and financial data, if they want to maximize the benefits of big data. "These types of data are subjected to different and sometimes conflicting federal and state regulation," if any regulation at all.22

Lastly, the ability to overcome de-identification is becoming easier due to "effective techniques ... to pull the pieces back together through 're-identification'."23 In fact, the very techniques used to analyze big data for legitimate purposes are the same advanced algorithms and technologies that allow re-identification of otherwise anonymous data.24 Moreover, "meaningful de-identification may strip the data of both its usefulness and the ability to ensure its provenance and accountability."25 In other words, de-identification is not as useful as it once was and further stripping data in an effort to overcome this fact could well extinguish any value the data may have (using the example above, car type and salary may still provide marketers with meaningful information (e.g., individuals with a similar salary may be interested in that car type), but the information "white Honda" alone is worthless).26

The consequences of all this are either 1) biomedical researchers are deprived of valuable data or provided meaningless de-identified data, or 2) individuals have no idea that their information is being processed for research purposes. Both the benefits and obstacles relating to big data and biomedical research led to the WH Report's recognition that we may need "to look closely at the notice and consent framework" because "focusing on controlling the collection and retention of personal data, while important, may no longer be sufficient to protect personal privacy."27 Further, as the PCAST Report points out, and as reflected in the WH Report, "notice and consent is defeated by exactly the positive benefits that big data enables: new, non-obvious, unexpectedly powerful uses of data."28 So what does this new approach look like?

Alternative Approach to Big Data: Focus on Use, Not Collection29

The WH Report does not provide specific proposals. Rather, it suggests a framework for a new approach to big data that focuses on the type of use of such data and associated security controls, as opposed to whether notice was provided and consent obtained at the point of its collection. Re-focusing attention to the context and ways big data is used (including the ways in which results generated from big data analysis are used) could have many advantages for individuals and biomedical researchers. For example, as noted above, the notice and consent model places the burden on the individual to manage all of the relevant privacy notices applicable to the processing of that individual's data and provides no backstop when those efforts fail or no attempt to manage notice provisions is made. Where the attention focuses on the context and uses of data, it shifts the burden of managing privacy expectations to the data collector and it holds entities that utilize big data (e.g., researchers) accountable for how data is used and any negative consequences it yields.30

The following are some specific considerations drawn from the reports regarding how a potential use framework might work:

  • Provide that all information used by researchers, regardless of the source, is subject to reasonable privacy protections similar to those prescribed under HIPAA.31 For example, any data relied upon by researchers can only be used and shared for biomedical research purposes.
  • Create special authorities or bodies to determine reasonable uses for big data utilized by researchers so as to realize the potential of big data while preserving individual privacy expectations.32 This would include recognizing and controlling harmful uses of data, including any actions that would lead to an adverse consequence to an individual.33
  • Develop a central research database for big data accessible to all biomedical researchers, with universal standards and architecture to facilitate controlled access to the data contained therein.34
  • Provide individuals with notice and choice whenever big data is used to make a decision regarding a particular individual.35
     
  • Where individuals may not want certain data to enter the big data ecosystem, allow them to create standardized data use profiles that must be honored by data collectors. Such profiles could prohibit the data collector from sharing any information associated with such individuals or their devices.
  • Require reasonable security measures to protect data and any findings derived from big data, including encryption requirements.36
     
  • Regulate inappropriate uses or disclosures of research information, and make parties liable for any adverse consequences of privacy violations.37

By offering these suggestions for public debate, the WH and PCAST reports have only initiated the discussion of a new approach to privacy, big data and biomedical research. Plainly, these proposals bring with them numerous questions and issues that must be answered and resolved before any transition can be contemplated (notably, what are appropriate uses and who determines this?).

Conclusion

Technologies utilizing the iOS 8 SDK, including HealthKit and HomeKit, illustrate the technological growth contributing to the big data environment. The WH and PCAST reports exemplify the endless possibilities that can be derived from this environment, as well as some of the important privacy issues affecting our ability to harness these possibilities. The reports constitute their authors' consensus view that the existing approach to big data and biomedical research restricts the true potential big data can have on research, while providing individuals with little-to-no meaningful privacy protections. Whether the suggestions contained in the WH and PCAST reports will be – or should be – further developed is an open question that will undoubtedly lead to a healthy debate. Yet, in the case of the PCAST Report, the sheer diversity of players recognizing big data's potential and associated privacy implications – including, but not limited to, leading representatives and academics from the Broad Institute of Harvard and MIT, UC-Berkeley, Microsoft, Google, National Academy of Engineering, University of Texas at Austin, University of Michigan, Princeton University, Zetta Venture Partners, National Quality Forum and others – provides hope that this potential will one day be realized – in a way that appropriately protects our privacy.38

WH Report Summary: click here.

PCAST Report Summary: click here.

 Footnotes

1 WH Report, p. 2.

2 See Apple's June 2, 2014, press release, Apple Releases iOS 8 SDK With Over 4,000 New APIs, last found at http://www.apple.com/pr/library/2014/06/02Apple-Releases-iOS-8-SDK-With-Over-4-000-New-APIs.html.

3 Id.

4 Id.

5 Id.

6 Id.

7 The White House and PCAST issued summaries of their respective reports, including their policy recommendations, which can be easily found at the links following this article.

8 WH Report, p. 7.

9 WH Report, p. 2.

10 WH Report, p. 5.

11 WH Report, p. 23.

12 WH Report, p. 3.

13 WH Report, p. 23.

14 WH Report, p. 6 (the WH Report includes two research-related examples of the impact of big data on research, including a study whereby the large number of data sets made "the critical difference in identifying the meaningful genetic variant for a disease.").

15WH Report, p. 23.

16 WH Report, p. 23.

17 WH Report, p. 23.

18 In privacy law, "anonymous" data is often considered a subset of "de-identified" data. "Anonymized" data means the data has been de-identified and is incapable of being re-identified by anyone. "Pseudonymized" data, the other primary subset of "de-identified" data, replaces identifying data elements with a pseudonym (e.g., random id number), but can be re-identified by anyone holding the key. If the key was destroyed, "pseudonymized" data would become "anonymized" data.

19 PCAST Report, p. 38.

20 PCAST Report, p. 38.

21 WH Report, p. 23.

22 WH Report, p. 23.

23 WH Report, p. 8.

24 WH Report, p. 54; PCAST Report, pp. 38-39.

25 WH Report, p. 8.

26 The PCAST Report does recognize that de-identification can be "useful as an added safeguard." See PCAST Report, p. 39. Further, other leading regulators and academics consider de-identification a key part of protecting privacy, as it "drastically reduces the risk that personal information will be used or disclosed for unauthorized or

malicious purposes." Dispelling the Myths Surrounding De-identification: Anonymization Remains a Strong Tool for Protecting Privacy, Ann Cavoukian, Ph.D. and Khaled El Emam, Ph.D. (2011), last found at http://www.ipc.on.ca/images/Resources/anonymization.pdf. Drs. Cavourkian and El Emam argue that "[w]hile it is clearly not foolproof, it remains a valuable and important mechanism in protecting personal data, and must not be abandoned." Id.

27 WH Report, p. 54.

28 PCAST Report, p. 38; WH Report, p. 54.

29 This approach is not one of the official policy recommendations contained in the WH Report. However, as discussed above, the WH Report discusses the impact of big data on biomedical research, as well as this new approach, extensively. Further, to the extent order has any meaning, the first recommendation made in the PCAST Report is that "[p]olicy attention should focus more on the actual uses of big data and less on its collection and analysis." PCAST Report, pp. 49-50.

30 WH Report, p. 56.

31 WH Report, p. 24.

31 WH Report, p. 23.

33 PCAST Report, p. 44.

34 WH Report, p. 24.

35 PCAST Report, pp. 48-49.

36 PCAST Report, p. 49.

37 PCAST Report, pp. 49-50.

38 It must be noted that many leading regulators and academics have a different view on the importance and role of notice and consent, and argue that these principles in fact deserve more focus. See, e.g., The Unintended Consequences of Privacy Paternalism, Ann Cavoukian, Ph.D., Dr. Alexander Dix, LLM, and Khaled El Emam, Ph.D. (2014), last found at http://www.privacybydesign.ca/content/uploads/2014/03/pbd-privacy_paternalism.pdf.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Emails

From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.