RISKS-LIST: Risks-Forum Digest Wedesday 18 December 2019 Volume 31 : Issue 51

ACM FORUM ON RISKS TO THE PUBLIC IN COMPUTERS AND RELATED SYSTEMS (comp.risks) Peter G. Neumann, moderator, chmn ACM Committee on Computers and Public Policy

***** See last item for further information, disclaimers, caveats, etc. ***** This issue is archived at <http://www.risks.org> as
<http://catless.ncl.ac.uk/Risks/31.51>
The current issue can also be found at
<http://www.csl.sri.com/users/risko/risks.txt>

Contents:
Human error installing SCADA system leads to 7.5 million gallons of
raw sewage dumped in Valdosta, GA
Killer Robots Aren't Regulated. Yet. (Jonah M. Kessel)
Earth Enters Unknown as Magnetic North Pole Continues Push Toward
Russia, Crosses Greenwich Meridian (Sputnik News)
SpaceX to Make Starlink Satellites Dimmer to Lessen Impact on Astronomy
(Scientific American)
Smart lock has a security vulnerability that leaves homes open for attacks
(CNET)
Scores of sex offenders have state licenses to be electricians,
manicurists, and more. The official who found out got fired. (BostonGlobe)
Is Alexa Always Listening? How Amazon, Google, Apple Hear, Record
(Bloomberg)
Apple Used the DMCA to Take Down a Tweet Containing an iPhone
Encryption Key (VICE)
Phone-breaking Android hole revealed (Gadget)
Deepfakes are getting better. Should we be worried? (TheBostonGlobe)
Luggage tracking apps aren't 100% accurate. People are the weak link
(LATimes)
Internet of crap encryption: IoT gear is generating easy-to-crack keys
(The Register)
Prime Leverage: How Amazon Wields Power in the Technology World (NYTimes)
Cloud flaws expose millions of child tracking smartwatches (TechCrunch)
Thief Stole Payroll Data of 29,000 Facebook Employees (CISOmag)
Companies Ignoring Third-Party Breach Alerts (Security Boulevard)
Insurer Races to Fix Security Flaws After Whistleblower Alert
(Bank Infosecurity)
Audit knocks Mass. tax-collection agency (The Boston Globe)
How hacking the human heart could replace pill popping (BBC.com)
Bates v Post Office litigation - reliability of computers
Re: Election Security regulations in the U.S. (Dick Mills)
Re: What happens if your mind lives for ever on the Internet? (Martin Ward) Abridged info on RISKS (comp.risks)

----------------------------------------------------------------------

Date: Sun, 15 Dec 2019 22:04:46 -0500
From: Shawn Merdinger <shawnmer@gmail.com>
Subject: Human error installing SCADA system leads to 7.5 million gallons of
raw sewage dumped in Valdosta, GA

https://valdostatoday.com/news-2/local/2019/12/human-error-led-to-massive-valdosta-sewage-spill/

"On December 9, 2019, the staff at the Withlacoochee Wastewater Treatment
plant notified Environmental Services personnel to inform them that flow
into the plant had decreased by 50% over the previous few days. After a
brief investigation, utility personnel noticed that a contractor working on
the city's SCADA system disconnected a reference cable at the Remerton Lift Station for testing and failed to reconnect it. As a result of the incident, the lift station's level indicator and alarm agent were disconnected. The
lift station's alarm agent system did not operate as it normally would, bypassing the alert notification that is typically sent to utility staff
when there is an issue at a lift station.

Based on the flow information collected, approximately 7,592,910 gallons discharged from a manhole into Sugar Creek adjacent to the 1800 block of
Norman Drive."

[Garbage In, Garbage Out: with a coochee-coup. PGN]

------------------------------

Date: December 14, 2019 18:53:07 JST
From: Dewayne Hendricks <dewayne@warpspeed.com>
Subject: Killer Robots Aren't Regulated. Yet. (Jonah M. Kessel)

Jonah M. Kessel, *The New York Times*, 13 Dec 2019
*Killing in the Age of Algorithms* is *The New York Times* documentary examining the future of artificial intelligence and warfare. https://www.nytimes.com/2019/12/13/technology/autonomous-weapons-video.html

Times reporters traveled to Russia, Switzerland, California and Washington, D.C., talking to experts in the commercial tech, military and AI
communities. Below are some key points and analysis, along with extras from the documentary.

Do I need to worry about a Terminator knocking on my door?

Most experts say you can rest easy, for now. Weapons that can operate like human soldiers are not something they see in our immediate future. Although there are varying opinions, most agree we are far from achieving artificial general intelligence, or A.G.I., that would allow for Terminators with the
kind of flexibility necessary to be effective on today's complex
battlefield.

However, Stuart J. Russell, a professor of computer science at the University of California, Berkeley, who wrote an influential textbook on artificial intelligence, says achieving A.G.I. that is as smart as humans is inevitable.

So where are we now?

There are many weapons systems that use artificial intelligence. But instead
of thinking about Terminators, it might be better to think about software transforming the tech we already have.

There are weapons that use artificial intelligence in active use today, including some that can search, select and engage targets on their own, attributes often associated with defining what constitutes a lethal
autonomous weapon system (a.k.a. a killer robot).

In his book *Army of None: Autonomous Weapons and the Future of War*, the
Army Ranger turned policy analyst Paul Scharre explained, ``More than 30 nations already have defensive supervised autonomous weapons for situations
in which the speed of engagement is too fast for humans to respond.''

Perhaps the best known of these weapons is the Israel Aerospace Industries Harpy, an armed drone that can hang out high in the skies surveying large
areas of land until it detects an enemy radar signal, at which point it
crashes into the source of the radar, destroying both itself and the target.

The weapon needs no specific target to be launched, and a human is not necessary to its lethal decision making. It has been sold to Chile, China, India, South Korea and Turkey, Mr. Scharre said, and the Chinese are
reported to have reverse-engineered their own variant..

``We call them precursors,'' Mary Wareham, advocacy director of the arms division at Human Rights Watch, said in an interview between meetings at the United Nations in Geneva. ``We're not quite there yet, but we are coming
ever closer.''

So when will more advanced lethal autonomous weapons systems be upon us?

``I think we're talking more about years not decades,'' she said.

But for the moment, most weapons that use AI have a narrow field of use and aren't flexible. They can't adapt to different situations.

``One of the things that's hard to understand unless you've been there is
just the messiness and confusion of modern warfare,'' Mr. Scharre said in an interview.''

``In all of those firefights,'' he explained, ``there was never a point
where I could very clearly say that it was 100 percent that the person I was looking at down the scope of my rifle was definitely a combatant.

Soldiers are constantly trying to gauge -- is this person a threat? How
close can they get to me? If I tell them to stop, does that mean that they didn't hear me or they didn't understand? Maybe they're too frightened to react? Maybe they're not thinking? Or maybe they're a suicide bomber and they're trying to kill me and my teammates.''

Mr. Scharre added, ``Those can be very challenging environments for robots
that have algorithms they have to follow to be able to make clear and
correct decisions.''

Although current AI is relatively brittle, that isn't stopping militaries
from incorporating it into their robots. In his book, which was published in 2018, Mr. Scharre wrote that at least 16 countries had armed drones, adding that more than a dozen others were working on them.

------------------------------

Date: Sat, 14 Dec 2019 09:02:05 -1000
From: geoff goodfellow <geoff@iconia.com>
Subject: Earth Enters Unknown as Magnetic North Pole Continues Push Toward
Russia, Crosses Greenwich Meridian (Sputnik News)

*Earlier this year, US National Oceanic and Atmospheric Administration and
the British Geological Survey (BGS) were forced to update the World Magnetic Model a year ahead of schedule due to the speed with which the magnetic
north pole is shifting out of the Canadian Arctic and toward Russia's
Siberia.*

EXCERPT:

The BGS and the US National Centers for Environmental Information has
released a new update to the World Magnetic Model this week, confirming that the magnetic north pole, whose coordinates are crucial for the navigation systems used by governments, militaries and a slew of civilian applications,
is continuing its push toward Siberia.

``The WMM2020 forecasts that the northern magnetic pole will continue
drifting toward Russia, although at a slowly decreasing speed -- down to
about 40 km per year compared to the average speed of 55 km over the past twenty years,'' the US agency said in a press statement. <https://www.ncei.noaa.gov/news/world-magnetic-model-2020-released>

The data confirmed that this year, the magnetic north pole passed to within
390 km of the geographic North Pole, and crossed the Greenwich (prime) meridian. Compilers also confirmed that the Earth's magnetic field is continuing to weaken, at a rate of about 5 percent every 100 years. [...]

https://sputniknews.com/science/201912131077566386-earth-enters-unknown-as-magnetic-north-pole-continues-push-toward-russia-crosses-greenwich-meridian/

------------------------------

Date: Sat, 14 Dec 2019 16:47:27 +0800
From: Richard Stein <rmstein@ieee.org>
Subject: SpaceX to Make Starlink Satellites Dimmer to Lessen Impact on
Astronomy (Scientific American)

https://www.scientificamerican.com/article/spacex-to-make-starlink-satellites-dimmer-to-lessen-impact-on-astronomy/.

See SpaceX's Starlink Could Change The Night Sky Forever, And Astronomers
Are Not Happy, for a brief note outlining astronomer's umbrage. http://catless.ncl.ac.uk/Risks/31/28#subj1.1

"So now the company plans to treat one of the Starlink satellites with a special coating, when the next group goes in late December, according to
SpaceX president and chief operating officer Gwynne Shotwell."

I wonder what's in SpaceX's 'secret anti-reflective' sauce? Hopefully, the coating won't chip or flake off the Starlink payload while deployed in
orbit.

------------------------------

Date: Sat, 14 Dec 2019 11:19:06 +0200
From: Amos Shapir <amos083@gmail.com>
Subject: Smart lock has a security vulnerability that leaves homes open for
attacks (CNET)

Yet another IOT vulnerability story:

https://www.cnet.com/news/smart-lock-has-a-security-vulnerability-that-leaves-homes-open-for-attacks/?utm_source=join1440&utm_medium=email&utm_placement=etcetera

There are no details in the article, but it seems to be a case of
unencrypted communication between a "smart lock" and the phone app which controls it.

------------------------------

Date: Sun, 15 Dec 2019 11:17:50 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Scores of sex offenders have state licenses to be electricians,
manicurists, and more. The official who found out got fired. (BostonGlobe)

https://www.bostonglobe.com/metro/2019/12/14/scores-registered-sex-offenders-have-state-licenses-electricians-manicurists-and-more-the-official-who-found-out-got-fired/hJAnvmdU7RqZg6MdvodunJ/story.html

------------------------------

Date: Sun, 15 Dec 2019 21:02:52 -0500
From: Gabe Goldberg <gabe@gabegold.com>
Subject: Is Alexa Always Listening? How Amazon, Google, Apple Hear, Record
(Bloomberg)

https://www.bloomberg.com/news/features/2019-12-11/silicon-valley-got-millions-to-let-siri-and-alexa-listen-in

------------------------------

Date: Thu, 12 Dec 2019 23:10:55 -0500
From: Gabe Goldberg <gabe@gabegold.com>
Subject: Apple Used the DMCA to Take Down a Tweet Containing an iPhone
Encryption Key (VICE)

https://www.vice.com/amp/en_us/article/pkeeay/apple-dmca-take-down-tweet-containing-an-iphone-encryption-key

------------------------------

Date: Fri, 13 Dec 2019 03:05:16 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Phone-breaking Android hole revealed (Gadget)

https://gadget.co.za/phone-breaking-android-hole-revealed/

------------------------------

Date: Sat, 14 Dec 2019 16:12:46 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Deepfakes are getting better. Should we be worried? (TheBostonGlobe)

https://www.bostonglobe.com/2019/12/13/opinion/deepfakes-are-coming-what-do-we-do/

------------------------------

Date: Sun, 15 Dec 2019 10:48:17 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Luggage tracking apps aren't 100% accurate. People are the weak
link (LATimes)

https://www.latimes.com/business/story/2019-11-06/airline-luggage-tracking-apps-problems

------------------------------

Date: Mon, 16 Dec 2019 11:24:20 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Internet of crap encryption: IoT gear is generating easy-to-crack
keys (The Register)

https://www.theregister.co.uk/2019/12/16/internet_of_crap_encryption/

------------------------------

Date: Tue, 17 Dec 2019 11:42:37 -0500
From: Gabe Goldberg <gabe@gabegold.com>
Subject: Prime Leverage: How Amazon Wields Power in the Technology World
(NYTimes)

https://www.nytimes.com/2019/12/15/technology/amazon-aws-cloud-competition.html

------------------------------

Date: Wed, 18 Dec 2019 09:03:30 -0800
From: Lauren Weinstein <lauren@vortex.com>
Subject: Cloud flaws expose millions of child tracking smartwatches
(TechCrunch)

https://techcrunch.com/2019/12/18/cloud-flaws-millions-child-watch-trackers/

[Also noted by Gabe Goldberg. PGN]

------------------------------

Date: Tue, 17 Dec 2019 11:28:45 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Thief Stole Payroll Data of 29,000 Facebook Employees (CISOmag)

https://www.cisomag.com/thief-stole-payroll-data-of-29000-facebook-employees/

------------------------------

Date: Tue, 17 Dec 2019 11:30:09 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Companies Ignoring Third-Party Breach Alerts (Security Boulevard)

https://securityboulevard.com/2019/12/companies-ignoring-third-party-breach-alerts/

------------------------------

Date: Tue, 17 Dec 2019 11:33:01 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Insurer Races to Fix Security Flaws After Whistleblower Alert
(Bank Infosecurity)

Report: Blue Cross and Blue Shield Minnesota Had Thousands of Old 'Critical' Vulnerabilities

https://www.bankinfosecurity.com/insurer-races-to-fix-security-flaws-after-whistleblower-alert-a-13508

------------------------------

Date: Tue, 17 Dec 2019 11:50:00 -0500
From: Monty Solomon <monty@roscom.com>
Subject: Audit knocks Mass. tax-collection agency (The Boston Globe)

`Incredibly sensitive' data is open to cyberattack at Mass. tax-collection agency, audit report says

https://www.bostonglobe.com/metro/2019/12/16/audit-knocks-state-tax-agency/D6SP1VxV5eGayVRYzZYCTL/story.html

------------------------------

Date: Wed, 18 Dec 2019 15:50:10 +0800
From: Richard Stein <rmstein@ieee.org>
Subject: How hacking the human heart could replace pill popping (BBC.com)

This BBC article suggests that an implanted medical device can improve your quality of life. https://www.bbc.com/future/article/20191216-how-hacking-the-human-heart-could-replace-pill-popping

Get an implanted device, fill it with your prescription(s), and set the dispensation timer (every X hours) or delivery trigger condition (blood
glucose threshold). Convenient, no? With an implant, the recipient is
relieved from fetching a glass of water to assist medicine consumption,
"where is my medicine" moments, or "fingertip prick, blood glucose measure,
and insulin inject" duties. Refill the reservoir periodically, like
recharging a mobile electronic device.

Device implantation is a highly personal choice: to sustain longevity, a candidate recipient may have no other options available to manage a chronic
or acute condition. Elective device implantation is a significant
life-changing and potentially life-threatening decision.

What questions do you ask a medical provider who recommends device implantation? What information do you need to make an informed decision?
What are the implanted device choices? What about post-implant quality of
life? How will the implant either change, diminish, or improve life quality? How often are explants (device removals) performed for the candidate device choice? What are implant risks and their occurrence probabilities? Why does your physician recommend manufacturer X's device, and not a competitor Y's? Does your physician receive payment or other incentive from manufacturer X
to implant their device? What criteria drive device selection that's
relevant to your case?

These questions are difficult for a patient to ask their physician. A
patient often consciously relies on physician trust to guide a "go or no-go" decision. You hold your physician in high regard. You rely on them to treat
you according to the Hippocratic Oath --- that's their career-long pledge to serve your interests. While you can often trust your physician, can you automatically extend this trust to the manufacturer that supplies the tools
and devices a physician uses to treat your condition?

I cannot give a binary 'yes' or 'no' answer. Risk, especially risks for implanted cardiac devices, constitutes a measure that is too important to ignore.

In this note, I attempt to estimate an probability for adverse event
experience arising in cardiac-related implantable device recipients: My analysis attempts to answer: "What is the probability of experiencing a malfunction or injury or death (identified as adverse events) following implantation of a pacemaker or defibrillator or electrical stimulus/sensing lead?"

I use freely available public, and professionally vetted/reviewed,
literature and government sources as noted below. Basic arithmetic is used
for computation.

[See http://catless.ncl.ac.uk/Risks/30/53#subj1.1 for a notable book on
implanted medical devices and their risks -- especially as experienced by
one person implanted with a neuro-stimulator.]

FDA's MAUDE and TOTAL PRODUCT LIFE CYCLE (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm)
tools collate submitted device report records. They are used to capture
adverse events (identified by the FDA as: DEATH, INJURY, MALFUNCTION, NOT SPECIFIED, OTHER) arising from, or possibly attributed to, implanted cardiac devices (defibrillators, pacemakers, electrical leads, etc.).

To perform the analysis, I estimate an aggregate adverse event count over a given 42 month interval comprising 01JAN2016-31JUL2019. I use public sources
of device implant rates to calculate a non-zero probability that an adverse event will impact a recipient. That the aggregation is applied across
multiple product codes (as shown below), implies that a recipient is
implanted with a defibrillator or pacemaker + electrical stimulus leads.

I do not attempt to segregate and identify probabilities attributed to
partial implant/explant, such as electrical stimulus lead explantation and implantation with a new one. The term 'device' used here implies pacemaker, defibrillator, and leads. It may also mean a big component of a pacemaker (pulse generator, but not the pacemaker's enclosure) or defibrillator that needs to be explanted or implanted.

The FDA website clearly states a caveat about using MAUDE data to calculate event rates: "MAUDE data is not intended to be used either to evaluate rates
of adverse events or to compare adverse event occurrence rates across
devices." (See https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude).
Caveat emptor!

MAUDE content shows that on some calendar days, over 500 medical device
reports are submitted. MAUDE's web interface will only retrieve a maximum of 100 reports for any single day of interest (e.g. start date: 29JAN2017 and
end date: 29JAN2017). Hitting the MAUDE retrieval limit during search may
align with a manufacturer device recall campaign that requires a report submission storm to comply with regulations.

The analysis was aided by pulling the raw zip files from https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude
to process and cleanse them to enable evaluation. A few simple PYTHON
programs were used in this process.

MAUDE and TPLC afford a means to aggregate, to count, adverse event
density. This density can be combined with published, peer-reviewed sources
to estimate a post-implant adverse event occurrence probability. MAUDE substantially captures adverse event reports submitted by US-based
healthcare providers, manufacturer device manufacturers, and recipients.
Device manufacturers apparently submit the vast majority of MAUDE reports.

A small percentage (guestimate is ~1-2%) are submitted from manufacturer
device representatives or healthcare providers for recipient adverse events
in other countries (e.g., Singapore-based device representatives or
healthcare provider submitted ~1000 reports between 01JAN2016-31JUL2019, if memory serves). Other countries rely on the same manufacturers (MEDTRONIC, BOSTON SCIENTIFIC, BIOTRONIX GMBH, ST. JUDE MEDICAL, GUIDANT, GREATBATCH MEDICAL, OSCOR, etc.) as the US healthcare system for implantable cardiac devices.

A patient's medical condition(s), and/or change in condition(s), often
serves as a significant justification to prepare and submit a medical device report that characterizes an adverse event. Comprehensive cardiac and electrophysiological knowledge is required to accurately assess and properly characterize an adverse event.

The investigation used the following MAUDE product codes, comprising 16 distinct cardiac implantable device types, to estimate post-implant adverse event probability noted below.

DTB|Permanent Pacemaker Electrode
DTD|Pacemaker Lead Adaptor
DXY|Implantable Pacemaker Pulse-Generator
LWP|Implantable Pulse Generator, Pacemaker (Non-Crt)
LWS|Implantable Cardioverter Defibrillator (Non-Crt)
MRM|Defibrillator, Implantable, Dual-Chamber
MXC|Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) MXD|Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) NIK|Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
NKE|Pulse Generator, Pacemaker, Implantable, With Cardiac
Resynchronization (Crt-P)
NVN|Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
NVY|Permanent Defibrillator Electrodes
NVZ|Pulse Generator, Permanent, Implantable
OJX|Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OSR|Pacemaker/Icd/Crt Non-Implanted Components
PNJ|Leadless Pacemaker

Each MAUDE product code identifier consist of 3 alphabetic characters. They are assigned to medical devices as part of FDA device registration and
approval processes. Each product code consists of devices of similar type
and function from different manufacturers. Thus, the NVY product code encompasses the class of Permanent Defibrillator Electrodes manufactured or sold into the global marketplace that is subject to FDA regulation.

The TPLC tool aggregates adverse events for product codes, but assigns
unique terms to segregate event attribution into defect categories. As an example, the DTB product code (Permanent Pacemaker Electrode) reveals this TOP-10 tabular summary (TOTAL COUNT == 59835) reported and full traceable to the MAUDE system since 2016:

DEVICE PROBLEMS COUNT

High Capture Threshold 9132
Under-Sensing 7738
Over-Sensing 7525
Adverse Event Without
Identified Device or Use
Problem 7523
Device Dislodged or
Dislocated 7055
High impedance 6255
Failure to Capture 5155
Capturing Problem 3303
Fracture 3299
Signal Artifact 2850

Under-sensing occurs when the pacemaker signal amplifier is too insensitive
-- the gain is too low -- to detect a portion of the recipient's native electrical heart activity. In contrast, Over-sensing occurs if the pacemaker signal amplifier gain is too high, leading the device to detect
inappropriate signals, like skeletal muscle movements.

The TPLC counts, and their assigned categories, are prepared and maintained
by an FDA panel who review the MAUDE adverse event reports. The 'DEVICE PROBLEM' labels comprise an arcane lexicon that non-subject matter
specialists struggle to interpret. A dictionary of TPLC category labels was
not found in the FDA website.

Based on the raw MAUDE records (downloaded in AUG2019), an analysis reveals that 240,232 device MALFUNCTIONS, INJURIES, DEATHS, NOT SPECIFIED, and OTHER adverse event records were reported between 01JAN2016-31JUL2019 (42 calendar months) for the 16 scoped cardiac-specific product code set. This adverse
event population might arise from accelerated battery discharge, lead displacement, inappropriate shock, and over 100 unique classification terms that characterize MAUDE medical device reports in TPLC.

The adverse incident density is notable. It likely implies, but does not guarantee, that ~240,000 UNPLANNED physician and emergency care center
visits by device recipients. Some events may have been reported via Internet monitoring, and deemed not sufficient to merit a provider visit on
inspection by the attendant. But we assume this event set constitutes an insignificant fraction (<<1%) during the 42 month reporting interval.

This paper
(https://academic.oup.com/europace/article/19/suppl_2/ii1/4100657) from the European Heart Rhythm Association (EHRA) estimates that 1.25 Million
pacemakers were implanted in 2016 worldwide. It further estimates an implantation rate of ~520 per million (~52 per 100,000) population. The EHRA pacemaker recipient average age is ~78 +/- 9 years.

In the US, the Agency for Healthcare Research and Quality (ahrq.gov)
reported 2015 statistics for pacemaker AND defibrillator implantation rate
of ~55 per 100,000 population, a value which substantially aligns with the
EHRA 2106 study. U.S. recipient's average age is ~72 years. The reporting
tool @ https://hcupnet.ahrq.gov/#setup yields this report after a little
setup.

The total recipients for device implantation, in the US, is given by the
rate of implantation per 100,000 times the total population:

In 2016, US census estimates 328,677,530 population. That's 3286.7 * 100,000 persons. 55 recipients/100,000 * (3286.7 * 100,000) ~= 180,768 recipients of defibrillator, pacemaker and device leads in 2016. This aggregate also
includes device explants -- removal of pacemaker, defibrillator and leads.

For the 42 month MAUDE reporting interval (01JAN2016-30JUL2019), we have 240,232 adverse event reports or 5,720 reports per month.

5,720 adverse events per month DIVIDED by 180,768 cardiac device recipients
= 3.16% probability to experience a monthly adverse event per 2016 census
data.

If ~3% of implanted cardiac device recipients experience unplanned
healthcare provider visitations, it represents a significant tax on the delivery system -- an extra ~5720 unplanned visits.

Device recipients often have no alternative other than implantation to
sustain their longevity. The estimated adverse event rate from implanted cardiac devices suggests that device manufacturers must pursue methods to suppress adverse events that initiate unplanned visits.

If implanted device sensing issues constitute a significant cause of
unplanned visits, it suggests that signal processing algorithms may require enhancement. Sustained research to improve implanted device reliability must become an industrial priority.

Before electing to receive a prescription-dispensing implant, especially for cardiac care, ask your healthcare provider to offer statistics about adverse events that may initiate an unplanned visit. It is imperative for
well-informed consumers to understand and consider the risks arising from implanted devices BEFORE the procedure.

Glossy manufacturer product literature may not detail sufficient historical adverse event probabilities for a device implant that informed consumer
choice requires.

Exploring FDA's medical device "systems of record," as embodied by the FDA's MAUDE and TPLC data repositories and reporting tools, can be enlightening
and frightening. Substantial technical information about manufacturer
implanted device issues are identifiable that may impact your decision to integrate them into your physiology. Implanted medical device manufacturer success depends on consistently beneficial patient outcomes. While
apparently small, a demonstrable risk weighs against achievement.

------------------------------

Date: Tue, 17 Dec 2019 13:05:18 +0000
From: Stephen Mason <stephenmason@stephenmason.co.uk>
Subject: Bates v Post Office litigation - reliability of computers

You might have picked up that the judge issued his (313 page) judgment yesterday with 3 appendices in the English case of Bates v Post Office
Limited. They are all available here: https://www.judiciary.uk/judgments/bates-others-v-post-office/

I am told by Tim McCormack [https://problemswithpol.wordpress.com/] that the judge went into detail about the meaning of *robust* -- although only discussing what the two parties had to say on the topic, and none of the discussions in chapter 6 of Electronic Evidence were discussed at all [the solicitors and barrister for the claimants were made aware of the
practitioner text Electronic Evidence].

[Stephen, Don't forget *resilience*; robustness is not enough. PGN]

Electronic Evidence is open source and a download from here: http://ials.sas.ac.uk/about/about-us/people/stephen-mason

Here are 3 relevant posts in relation to the opening speech of the barrister for the Post Office:

The use of statistics and software code https://ials.blogs.sas.ac.uk/2019/06/26/the-use-of-statistics-and-software-code/

The use of the word *robust* to describe software code https://ials.blogs.sas.ac.uk/2019/06/25/the-use-of-the-word-robust-to-descri be-software-code/

Robustness and reliability in computer systems https://ials.blogs.sas.ac.uk/2019/06/28/robustness-and-reliability-in-computer-systems/

I will begin to read through the judgment over the next few days/weeks, and compare it to the transcript of the trial of Seem Misra, where the
prosecution kept on asserting the system was robust then. I published the complete transcript of the Seema Misra case here:

Introduction: https://journals.sas.ac.uk/deeslr/article/view/2217

Transcript at the bottom of this page: https://journals.sas.ac.uk/deeslr/issue/view/328

I'd appreciate people's thoughts on this when you get around to looking at
it.

The importance of this case is this: Seema Misra and others were prosecuted, and reliance was made on the robustness of the Horizon system without any evidence that the system was robust or what robust meant. It also appears
that evidence given at her trial was dubious. I aim to bring out these
issues, and wondered whether if anybody had the time and patience to
consider an article for next year's Digital Evidence and Electronic
Signature Law Review? https://journals.sas.ac.uk/index.php/deeslr (also available via the HeinOnline subscription service).

We are going to do a 5th edition of Electronic Evidence next year, coming
out in 2021, and it would be very helpful to have a technical view on these issues for me to cite.


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