Your Body and Your Brain “At Risk” – The Business of Recalling Biomedical Implants

Source: http://www.notey.com/blogs/medical--AND--biotech

Source: http://www.notey.com/blogs/medical--AND--biotech

Consumer electronics are “wants” bought by people who have purchasing power. These might range from human aids like calculators and robot vacuum cleaners to entertainment-driven electronics like smart TVs and tablets, to personal assistants like smart watches and fitness trackers. While most do not consider biomedical implants like heart pacemakers and brain pacemakers to be “consumer electronics”, by definition they are “a good bought for personal rather than commercial use”. The only paradox in this instance is that this suite of biomedical implantables are really “needs” as opposed to “wants”. Patients have a choice on whether or not to adopt this emerging technology, but most say that opting in is the only real option to maintaining their quality of life and longer-term wellbeing.

In the general consumer market, taking back a faulty product simply requires an original proof of purchase so an item can be validated as still being under warranty. In the case of biomedical implantables, a recipient simply cannot take back an implant for repair if it malfunctions. Biomedical implantables are willingly embedded in the body of a consumer by a surgical team, and require special expertise for removal, replacement or maintenance (i.e. upgrade). The manufacturer, for example, cannot conduct the removal process, but a surgeon with the right equipment and human resource support (e.g. nurses) can. In 2010, one supplier of pacemakers, Medtronic Inc., had to pay $268 million to settle thousands of lawsuits that patients filed after a 2007 recall of a faulty heart defibrillator wire that caused at least 13 deaths. In other cases, battery packs have failed causing disruption to consumer implants, and more recently we have witnessed software code security vulnerabilities in heart pacemakers which have meant that recipients had to undergo a firmware upgrade in a doctor’s office, a procedure that takes up to 5 minutes and is non-invasive.

On the one hand, these pacemakers are life-sustaining and life-enhancing to their recipients, on the other hand they place voluntary human implantees at some level of risk. The various types of risks will be considered in this presentation as will the impact of “recalls” on consumer implantees.

This Medtronic YouTube Video is shown in the context of this educational presentation under "fair use" rights. Gary's story demonstrates the positive and life-changing impact a DBS can have on one's life if they are suffering from Parkinson's Disease.

Now read about another Gary here. Two part interview will appear shortly in IEEE Consumer Electronics Magazine.

Warning: The contents of this video are disturbing.

Warning: The contents of this video are disturbing.

Citation: Katina Michael, May 18, 2018, "Your Body and Your Brain “At Risk” – The Business of Recalling Biomedical Implants", Innovations in Health Technology Panel at the Governance of Emerging Technologies and Sciences: Law, Policy and Ethics.

Microchipping Beyond Body Modification: New ID for Ticketing and Transportation?

Always delighted to speak at events where the audience is ready to be challenged, and to challenge me back! Thank you Mixed Probus group (Kiama Harbourside) for the wonderful white wine, the delicious lunch we shared together, your willingness to take home and read a copy of IEEE Consumer Electronics Magazine, and your mindful commentary about the future of microchipping humans for medical and non-medical applications.

Title: Microchipping Beyond Body Modification: New ID for Ticketing and Transportation?

Abstract: For some time we have witnessed the advent of humans bearing implantable devices for a myriad of non-functional uses. We have grown accustomed to people wearing tattoos on their faces and forearms, piercing noses and tongues, and even implanting wedges of silicon beneath the skin. All of these microchips have modified the body of the individual for mainly aesthetic purposes. Enter the emerging range of ID chips embedded beneath the skin that are now being trialled for ticketing in transit applications and transportation. The last 24 months have seen a spate of small-scale (even one-person participant observer trials) of people implanting unique ID chips into their bodies as part of functional application trials. We've seen people board a plane without a physical boarding pass in Scandanavia. We've seen people enter parking lots with just a wave of a hand in Glebe, NSW. We've seen people embed a chip that links to their mobile phone for payment. And more recently we've witnessed a local man from Sydney use his implantable device to board a train, instead of a physical PVC-based Opal Card. In effect, the man had embedded an Opal chip into his hand. This seminar will examine these single case studies and consider the pros and cons of going completely cashless and paperless for ticketing and transportation. Do you think this is our future? To be microchipped like dogs and cats? Or do you think it is technology better left outside the human body? Come and discuss these questions with peers in your local Municipality.

Participant Reflections:

  • Can easily see the benefits of microchip implants. Especially for medical records.
  • Convenience. Driver's license. Pension card. Passport.
  • Anti-terrorism measure.
    • Why not?
  • Autonomy, convenience.
  • Due process should be followed, if followed, there are no problems.
  • Control. Lack of control.
  • Computer hacking. Passwords.
  • Privacy problems.
  • Who can access your data? Personal information.
  • Ownership?
    • The Hospital. The Patient. The Person. The Company who Produced it. Anyone who has the right to access it. Health Insurance Provider.
  • False data. Reliability.
  • Inequality. Cost issue. Affordability. Haves and have-nots.

About the Speaker: Dr Katina Michael is a professor in the Faculty of Engineering and Information Sciences at the University of Wollongong. She joined UOW in 2002 after a career in telecommunications engineering at Nortel Networks. Her research is in the area of the social implications of emerging technologies with an emphasis on national security. Katina is the editor in chief of IEEE Technology and Society Magazine, and senior editor of IEEE Consumer Electronics Magazine. She resides in the Kiama Municipality with her husband and three children. Most days she can be found wandering Illawarra beaches for an hour or so. See also: www.uberveillance.com; www.katinamichael.com.

This talk has been commissioned by Kiama Mixed Probus group that will meet at the Kiama Leagues Club on August 2, 2017. Kiama Mixed Probus Club was instigated in 1994 by Philip and Marian Russell. More here.

Expected audience: 60 people.

From left to right (above): Helen Fox, Katina Michael, Marilyn, Diane Westgate and David Westgate. What a fantastic and happy environment with lots and lots of characters.

Mixed Probus Kiama Harbourside Group that meets once a month at the Kiama Leagues Club, Kiama, NSW (tables at right, out of view)

Mixed Probus Kiama Harbourside Group that meets once a month at the Kiama Leagues Club, Kiama, NSW (tables at right, out of view)

Hacking the Body: The Future of Persuasive Technologies in IOMT

The development of small wearables and tiny implantable devices that are tethered to mobile or desktop units have aided to realise the possibility of the Internet of Medical Things paradigm. This presentation will review the three P’s, pervasive diagnostics, personalised medicine and persuasive technology in the context of an end-to-end healthcare value chain. The future of IOMT is in the collection of discrete historical data and continuous real-time data incorporating not only static data like one’s DNA profile but real-time behavioural biometrics like one’s brain and heart activity. This presentation will emphasise the precautionary principle in considering the impact of IOMT on privacy and security. Notions of secondary use of personal data, retrospective use, bodily privacy, body hacking, and ‘death by Internet’ will be discussed. This presentation will be focused on raising awareness in biomedical device engineers of new end-user vulnerabilities posed by emerging devices within an uberveillance society for individual life sustainment and life enhancement.