How Could Commercial Terms of Use and Privacy Policies Undermine Informed Consent in the Age of Mobile Health?

Cynthia E. Schairer, Caryn Kseniya Rubanovich, and Cinnamon S. Bloss
AMA J Ethics. 2018;20(9):E864-872.

Abstract

Granular personal data generated by mobile health (mHealth) technologies coupled with the complexity of mHealth systems creates risks to privacy that are difficult to foresee, understand, and communicate, especially for purposes of informed consent. Moreover, commercial terms of use, to which users are almost always required to agree, depart significantly from standards of informed consent. As data use scandals increasingly surface in the news, the field of mHealth must advocate for user-centered privacy and informed consent practices that motivate patients’ and research participants’ trust. We review the challenges and relevance of informed consent and discuss opportunities for creating new standards for user-centered informed consent processes in the age of mHealth.

The info is here.

The Tech Industry’s War on Kids

Richard Freed
Medium.com
Originally published March 12, 2018

Here is an excerpt:

Fogg speaks openly of the ability to use smartphones and other digital devices to change our ideas and actions: “We can now create machines that can change what people think and what people do, and the machines can do that autonomously.” Called “the millionaire maker,” Fogg has groomed former students who have used his methods to develop technologies that now consume kids’ lives. As he recently touted on his personal website, “My students often do groundbreaking projects, and they continue having impact in the real world after they leave Stanford… For example, Instagram has influenced the behavior of over 800 million people. The co-founder was a student of mine.”

Intriguingly, there are signs that Fogg is feeling the heat from recent scrutiny of the use of digital devices to alter behavior. His boast about Instagram, which was present on his website as late as January of 2018, has been removed. Fogg’s website also has lately undergone a substantial makeover, as he now seems to go out of his way to suggest his work has benevolent aims, commenting, “I teach good people how behavior works so they can create products & services that benefit everyday people around the world.” Likewise, the Stanford Persuasive Technology Lab website optimistically claims, “Persuasive technologies can bring about positive changes in many domains, including health, business, safety, and education. We also believe that new advances in technology can help promote world peace in 30 years.”

While Fogg emphasizes persuasive design’s sunny future, he is quite indifferent to the disturbing reality now: that hidden influence techniques are being used by the tech industry to hook and exploit users for profit. His enthusiastic vision also conveniently neglects to include how this generation of children and teens, with their highly malleable minds, is being manipulated and hurt by forces unseen.

The article is here.

Mobile medical apps & FDA regulation

The Growth of the Health IT Sector and the Need for More Robust FDA Regulation

By Adam
Nurep
Originally posted on December 21, 2012


Over the last six years, there has been significant growth in the health technology sector (e.g. mobile medical apps), driven by advances in technology and an increase in venture capital (VC) funding. VCs have been lured into the space due to the perception of high returns on investment within shorter timeframes versus their traditional life science funds. The significant growth in this market has driven the need for increased scrutiny from the FDA in how these products should be regulated.

The FDA has the authority to regulate software if it falls within the broad definition of a “device”. It has further segmented medical devices into three classes; Class I, Class II and Class III. Class I devices don’t require FDA regulatory filing (i.e., 510(K), Premarket Approval Application (PMA)) whereas Class II requires 510(K) and Class III devices require a PMA. The class to which a device is assigned determines the type of premarketing submission/application required for FDA clearance, prior to product launch.

While the FDA has had policies in place for many years regarding the regulation of software/computer products, it has historically taken the position not to enforce the regulation unless the product interfaces directly with a medical device. In cases such as these, products have then been subjected to regulation as if they were a medical device. This caused problems for the manufacturers of these devices as there was no structured classification system based on a risk assessment, making it difficult to predict whether a device would end up being a Class I, II or III medical device. Furthermore, the rapid adoption of mobile technology within healthcare meant that there was a pressing need to develop specific guidelines around the regulation of these products also (out of the 14,558 medical apps currently available, only 75 have received clearance from the FDA).

The entire article is here.