Questions to ponder on body politics

  1. Who are you and does the government care?
  2. What are the proper roles of a government to the health/wealth of the governed?
  3. “The most vocal contributions to the ethical debates, Takala (2017) says, “tend to be either strongly against or adamantly for the new technologies. This tendency is furthered by the popular media, which prefers headline material.” Does the sensational tend to senses? Does it tend to “make sense”?
  4. “Research is suggesting,” Rich & Evans (2005) suggest “that people are obtaining health information not just from traditional medical sources but from newspapers, magazines, television etc.” Should the government regulate the transmission of medical/health information from these sources? 
  5. Politics in just about any context seems to be divisive, eliciting strong emotions and lowered rationales. How can we effectively discuss politics?
  6. Why/Are women’s bodies disproportionally controlled by governments?
  7. What legitimate interest does a government/state have in the health of its population? To whom can you appeal if a State is genuinely bad for your health?
  8. HUD Secretary Julian Castro recently remarked in a debate, “[J]ust because a woman — or let’s also not forget someone in the trans community, a trans female — is poor, doesn’t mean they shouldn’t have the right to exercise that right to choose. And so I absolutely would cover the right to have an abortion.” Should trans females have the right to have an abortion?
  9. Inherent to the practice of government is the (at least veiled) threat of “legitimated” violence – e.g., don’t pay your taxes, get brought to court; run from the police, get tazed by them; hurt someone, get hurt back. How do we ensure that such threats of/violence is indeed legitimate? How do we ensure it is righteous?
  10. What, if anything, should the government do on the following debated topics:
    • Compulsory vaccination of children;
    • Healthcare in general;
    • Homelessness;
    • Recreational drug use;
    • Right-to-try regulations; and
    • Right-to-die legislation?
  11. In the “heartbeat bill” (H.B. 481, “Living Infants Fairness and Equality (LIFE) Act”), the state Georgia amended its Official Code to create “two classes of persons: natural and artificial” in which natural persons are any human being “including an unborn child with a detectable human heartbeat”. Do you believe a heartbeat – “cardiac activity or the steady and repetitive rhythmic contraction of the heart” – a proper measure of the beginning of life? The end? How should a government demarcate?
  12. Was Thích Quảng Đức’s self-immolation of a legitimate use of political influence?
  13. Do we have more bodily liberty now than we have in the past? Will we have more in the future? In what ways? How do you know?
  14. Is our nation on the rise or the decline? 

BIOMEDE 458 Outline, a draft

  1. Week 1, An introduction to biomedical systems and signals
    1. Introductory Lab
  2. Week 2, Cardiac systems
    1. ECG Lab 1 and 2
      1. Reading 1: 4.i; 4.ii; 12.ii
      2. Reading 2: 8.i; 9.i; 12.i
  3. Week 3, Signals measurement
    1. ECG Lab 3 and 4
      1. Reading 3: 2.ii; 8.iii; 10.i
      2. Reading 4: 10.v; 10.vi; 11.i
    2. Big List of Medical Devices I
  4. Week 4, Cardiovascular systems
    1. ECG Lab 5 and 6
      1. Reading 5: 4.v; 12.iii; 12.iv
      2. Reading 6: 2.iv; 9.ii; 11.v
    2. ECG Notebook Review
    3. ECG Shareout
  5. Week 5, Signals processing
    1. Pulse Ox Lab 1 and 2
      1. Reading 7: 7.i; 7.ii; 8.v
      2. Reading 8: 11.ii; 11.iii; 12.viii
    2. Big List of Medical Devices II
    3. ECG Notebook Finalized
    4. ECG Reflection
  6. Week 6, Respiratory systems
    1. Pulse Ox Lab 3 and 4
      1. Reading 9: 4.iv; 9.iii; 12.v
      2. Reading 10: 2.iii; 11.iv; 12.vi
    2. ECG Lab Manual
    3. Roundtable article submission
  7. Week 7, Signals analysis
    1. Pulse Ox Lab 5 and 6
      1. Reading 11: 10.ii; 10.iii; 10.iv
      2. Reading 12: TBD
    2. Big List of Medical Devices III
    3. Pulse Ox Notebook Review
    4. Pulse Ox Shareout
    5. Homework
  8. Week 8, Systems integration
    1. Project proposals 1 and 2
      1. Reading 13: 4.v; 4.vi; TBD
      2. Reading 14: 2.i; 12.vii; 12.ix
    2. Pulse Ox Notebook Finalized
    3. Pulse Ox Reflection
  9. Week 9, A break
    1. Pulse Ox Lab Manual
  10. Week 10, Ethical roundtables
    1. Spirometry Lab 1 and 2
      1. Reading 15: 1.i; 1.ii; 3.ii
      2. Reading 16: 1.v; 6.i; 6.iv
    2. Big List of Medical Devices IV
    3. Roundtable discussion
  11. Week 11, Interviews: I. On law
    1. Spirometry Lab 3 and 4
      1. Reading 17: 3.i; 6.ii; 6.iii
      2. Reading 18: TBD
  12. Week 12, Interviews: II. On business
    1. Spirometry Lab 5 and 6
      1. Reading 19: 6.vi; 6.vii; 6.viii
      2. Reading 20: 3.iv; 3.v; 5.i
    2. Big List of Medical Devices V
    3. Spirometry Notebook Review
    4. Spirometry Shareout
  13. Week 13, Interviews: III. On regulation
    1. Project Lab 1 and 2
      1. Reading 21: 1.iii; 6.iii; TBD
      2. Reading 22: 3.i; 8.iii; 8.iv
    2. Spirometry Notebook Finalized
    3. Spirometry Reflection
  14. Week 14, Interviews: IV. On consequences
    1. Project Lab 3 and 4
      1. Reading 23: 5.ii; 5.iii; 5.iv
      2. Reading 24: 1.iv; 5.v; 13
    2. Big List of Medical Devices VI
    3. Spirometry Lab Manual
  15. Week 15, Philosophies of biomedical instrumentation
    1. Project Lab 5 and 6
    2. Project Notebook Review
  16. Week 16+, Ends 
    1. Project Lab 7
    2. Project Shareout
    3. Project Notebook Finalized
    4. Project Reflection
    5. Project Lab Manual

BIOMEDE 458 Readings, a draft

  1. Abdel-Aleem, Salah., “The Design and Management of Medical Device Clinical Trials Strategies and Challenges.” John Wiley, 2010. (https://search.lib.umich.edu/catalog/record/014327513)
    1. Chapter 1 – Challenges to the Design of Clinical Study
    2. Chapter 4 – Fraud and Misconduct in Clinical Trials
    3. Chapter 5 – Challenges to the Regulation of Medical Device
    4. Chapter 6 – Challenges of Global Clinical Studies and the CE Mark Process
    5. Chapter 8 – Bioethics in Clinical Research
  2. Baura, Gail D., “Medical Device Technologies a Systems Based Overview Using Engineering Standards.” Elsevier/Academic Press, 2012. (https://search.lib.umich.edu/catalog/record/011489120)
    1. Chapter 1 – Diagnosis and Therapy
    2. Chapter 2 – Electrocardiographs
    3. Chapter 9 – Hemodialysis Delivery Systems
    4. Chapter 11 – Pulse Oximeters
  3. Fries, Richard C., “Reliable Design of Medical Devices.” CRC Press, 2013. (https://search.lib.umich.edu/catalog/record/015118276)
    1. Chapter 7 – The FDA
    2. Chapter 12 – Liability
    3. Chapter 13 – Intellectual Property
    4. Chapter 32 – Transfer to Manufacturing
    5. Chapter 33 – Hardware Manufacturing
  4. Kaniusas, Eugenijus., “Biomedical Signals and Sensors I: Linking Physiological Phenomena and Biosignals.” Springer, 2012. (https://search.lib.umich.edu/catalog/record/016745783(
    1. Chapter 2.2 – Neurons and Receptors 
    2. Chapter 2.4 – Heart 
    3. Chapter 2.5 – Circulatory System 
    4. Chapter 2.6 – Respiratory System 
    5. Chapter 3.1 – Vital Phenomena and Their Parameters
    6. Chapter 3.2 – Parameter Behavior 
  5. Kendler, Jonathan. and Strochlic, Allison Y., “Usability Testing of Medical Devices.” CRC Press, Taylor & Francis Group, 2016. (https://search.lib.umich.edu/catalog/record/014995742)
    1. Chapter 3 – The Commercial Imperative
    2. Chapter 4 – Testing Costs
    3. Chapter 7 – Writing a Test Plan
    4. Chapter 12 – Conducting the Test
    5. Chapter 16 – Reporting Results
  6. Kucklick, Theodore R., “The Medical Device R&D Handbook.” CRC press, Taylor & Francis Group, 2013. (https://search.lib.umich.edu/catalog/record/015114086)
    1. Chapter 12 – Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory
    2. Chapter 14 – Intellectual Property Strategy for Med-Tech Start-Ups 
    3. Chapter 15 – Regulatory Affairs: Medical Device 
    4. Chapter 17 – Brief Introduction to Preclinical Research 
    5. Chapter 24 – Interview with J. Casey McGlynn 
    6. Chapter 25 – Keys to Creating Value for Early Stage Medical Device Companies 
    7. Chapter 27 – Medical Device Sales 101 
    8. Chapter 29 – How to Fail as an Entrepreneur 
  7. Liang, Hualou., Bronzino, Joseph D., and Peterson, Donald R., “Biosignal Processing Principles and Practices.” CRC Press/Taylor & Francis, 2013. (https://search.lib.umich.edu/catalog/record/012179290)
    1. Chapter 1 – Digital Biomedical Signal Acquisition and Processing
    2. Chapter 2 – Time–Frequency Signal Representations for Biomedical Signals 
  8. Norris, Michael., “Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices.” Wiley-Interscience, 2005. (https://search.lib.umich.edu/catalog/record/014327511)
    1. Chapter 1 – Biopotential amplifiers 
    2. Chapter 2 – Bandpass selection for biopotential amplifiers 
    3. Chapter 3 – Design of safe medical device prototypes
    4. Chapter 4 – Electromagnetic compatibility and medical devices
    5. Chapter 5 – Signal conditioning, data acquisition, and spectral analysis 
  9. Northrop, Robert B., “Noninvasive Instrumentation and Measurement in Medical Diagnosis.” CRC Press, Taylor & Francis Group, 2018.(https://search.lib.umich.edu/catalog/record/017413760)
    1. Chapter 4 – Measurement of Electrical Potentials and Magnetic Fields from the Body Surface 
    2. Chapter 9 – Plethysmography 
    3. Chapter 10 – Pulmonary Function Tests
  10. Semmlow, John L., “Circuits, Signals and Systems for Bioengineers : A MATLAB-basedIintroduction.” Academic Press, 2018. (https://search.lib.umich.edu/catalog/record/016172482)
    1. Chapter 1 – The Big Picture: Bioengineering Signals and Systems
    2. Chapter 2 – Signal Analysis in the Time Domain
    3. Chapter 3 – Signal Analysis in the Frequency Domain: The Fourier Series and the Fourier Transformation
    4. Chapter 4 – Signal Analysis in the Frequency Domain—Implications and Applications
    5. Chapter 13 – Analysis of Analog Circuits and Models
    6. Chapter 15 – Basic Analog Electronics: Operational Amplifiers
  11. Webster, John G., and Eren, Halit, “Measurement, Instrumentation, and Sensors Handbook: Electromagnetic, Optical, Radiation, Chemical, and Biomedical Measurement.” CRC Press, Taylor & Francis Group, 2014. (https://search.lib.umich.edu/catalog/record/015114037)
    1. Chapter 19 – Oscilloscope Voltage Measurement 
    2. Chapter 41 – Time Measurement 
    3. Chapter 42 – Frequency Measurement 
    4. Chapter 65 – Blood Pressure Measurement 
    5. Chapter 68 – Blood Chemistry Measurement 
  12. Wood, Andrew W., “Physiology, Biophysics, and Biomedical Engineering.” CRC Press, 2012. (https://search.lib.umich.edu/catalog/record/017414626) 
    1. Chapter 2 – Fundamentals of Electrical Circuits for Biomedicine
    2. Chapter 8 – Cardiac Biophysics 
    3. Chapter 10 – The Vascular System: Blood Flow Patterns in Various Parts of the Circulation 
    4. Chapter 11 – Cardiovascular System Monitoring 
    5. Chapter 12 – Respiratory Biophysics 
    6. Chapter 13 – Renal Biophysics and Dialysis 
    7. Chapter 16 – The Biophysics of Sensation—General 
    8. Chapter 20 – Physiological Signal Processing 
    9. Chapter 25 – Physiological Modeling 
  13. World Health Organization (WHO), “Medical Devices: Managing the Mismatch : An Outcome of the Priority Medical Devices Project.” Geneva, 2010.(https://search.lib.umich.edu/catalog/record/008939040, https://apps.who.int/iris/bitstream/handle/10665/44407/9789241564045_eng.pdf)
 

A resolution

To revise the Sexual Misconduct Umbrella Policy
 
Whereas, the University of Michigan released its draft “Sexual Misconduct Umbrella Policy” (the “Umbrella Policy”) addressing sexual and gender-based misconduct on October 15, 2019 (1);
 
Whereas, the Umbrella Policy holds that a hearing “to obtain information […] to make a determination of whether a Policy violation occurred” is expected (2) and that a “typical hearing may include […] questions by one party to the other(3), such as a Respondent, “an individual who is reported to have committed Prohibited Conduct” (4), questioning a Complainant, “an individual who is reported to have experienced Prohibited Conduct” (5), where Prohibited Conduct includes “Sexual Assault; Sexual Exploitation; Sexual Harassment; Gender-Based Harassment; Sexual and/or Gender-Based Stalking; Intimate Partner Violence; Sex and Gender-Based Discrimination; Retaliation; and Violation of Protective Measures” (6), (7);
 
Whereas, though the Umbrella Policy holds “a Complainant and a Respondent may have an adviser […] an individual chosen by a party to provide support and guidance during the review of a report of Prohibited Conduct” (8), such as “an advocate and/or an attorney” (9), it is unclear whether an adviser or an equivalent representative may be permitted to cross-examine a witness;
 
Whereas, the Supreme Court has held “where important decisions turn on questions of fact, due process requires an opportunity to confront and cross-examine adverse witnesses(10) as it is often critical to resolving factual disputes, a value to both Complainants and Respondents, serving the goal of reaching legitimate and fair decisions;
 
Whereas, the United States Court of Appeals for the Sixth Circuit has recognized that “Universities have a legitimate interest in avoiding procedures that may subject an alleged victim to further harm or harassment. And in sexual misconduct cases, allowing the accused to cross-examine the accuser may do just that(11);
 
Whereas, the United States Court of Appeals for the Sixth Circuit has recognized that “an individual aligned with the accused student can accomplish the benefits of cross-examination–its adversarial nature and the opportunity for follow-up–without subjecting the accuser to the emotional trauma of directly confronting [an] alleged attacker(12);
 
Whereas, the University has recognized “allowing an accused student to confront the claimant directly may subject an alleged victim to further harm or harassment” and that  “fear of having to confront, and discuss in detail, a sexual assault with the very individual accused of having committed the assault may well lead alleged victims not to report cases in the first instance” (13); and
 
Whereas, the University adopted the Umbrella Policy “with a commitment to: (1) eliminating, preventing, and addressing the effects of Prohibited Conduct; (2) fostering an environment where all individuals are well-informed and supported in reporting Prohibited Conduct; [and] (3) providing a fair and impartial process for all parties” (14); now, therefore, be it
 
Resolved, that the Senate Assembly urges the University to 
  1. Revise the Umbrella Policy to comply with due process and protect victims of sexual and gender-based misconduct;
  2. Prevent a Respondent from directly questioning a Complainant;
  3. Adopt a policy that includes cross-examination by a representative;
  4. View cross-examination of witnesses as serving the goal of reaching legitimate and fair decisions;
  5. Protect the Complainant from further harm or harassment, as might be caused by cross-examination by the Respondent;
  6. Create a forum where cross-examination of the Respondent and the Complainant may be conducted by a representative trained in the appropriate scope and manner of cross-examination;
  7. Recognize that fear of having to confront, and discuss in detail, a sexual and/or gender-based misconduct with the very individual accused of having committed the misconduct may well lead alleged victims not to report cases in the first instance; and
  8. Commit to eliminating, preventing, and addressing sexual and gender-based misconduct; foster an environment where all are informed and supported well; and provide a process with fairness for all.
 

(1) University of Michigan, Sexual Misconduct Umbrella Policy (October 15. 2019), https://sexualmisconduct.umich.edu/umbrella-policy/

(2) University of Michigan, Ann Arbor Student Procedures (October 4, 2019), Dearborn Student Procedures (October 14, 2019), Flint Student Procedures (October 14, 2019), § VII.C (pg. 16), https://sexualmisconduct.umich.edu/wp-content/uploads/2019/10/Studentprocedures_10.4.19_FINAL.pdf, https://sexualmisconduct.umich.edu/wp-content/uploads/2019/10/DearbornStudentprocedures.pdf, https://sexualmisconduct.umich.edu/wp-content/uploads/2019/10/FlintStudentProcedures.pdf 

(3) Id. § VII.C.6 (pg. 18, emphasis added)

(4) University of Michigan, Umbrella Policy (October 4, 2019), § II.F (pg. 3) https://sexualmisconduct.umich.edu/wp-content/uploads/2019/10/Policy_10.3.19_clean.pdf

(5) Id. § II.E (pg. 2)

(6) Id., § I (pg. 1)

(7) Id., § II.A (pg. 2)

(8) University of Michigan, Ann Arbor Student Procedures, Dearborn Student Procedures, Flint Student Procedures, § VII.A.6 (pg. 10)

(9) Id.

(10) Goldberg v. Kelly, 397 U.S. 254, 269 (1970) (emphasis added).

(11) Doe v. Baum, 903 F.3d 575, 583 (6th Cir. 2018) (emphasis added).

(12) Id (emphasis added).

(13) Appellee’s Pet. For Reh’g and Reh’g En Banc at 6, Doe v. Baum, No. 17-2213 (6th Cir. Sept. 24, 2018)

(14) University of Michigan, Umbrella Policy (October 4, 2019), § I (pg. 1)


Proposed by the Committee on Civil Rights and Liberties for the November 18, 2019 Senate Assembly meeting
Barry Belmont, Chair
Irina Aristarkhova
Edmund Graham
Rachael Kohl
Herman Love
Jennifer Matthews
Debby Mitchell
David Moran
Dinesh Pal
Samuel Rubinstein
Kate Saylor
Deirdre Spencer
Heather Walline
Matthew Zimmer


Questions to ponder on fear

1. What do you fear and why?
2. Is knowing what others fear a matter of privacy? What about other emotions? Will emotional/mental states ever be sufficiently measured by human beings?
3. Describing fear as a bodily response to a threat, Quirk (2015) describes the flight or flight response as a combination of increased breathing rate, increased blood pressure, increased heart rate, decreased pain sensitivity, etc., i.e., fear as a physiological function. Sometimes altered physiological functions allow performance in extreme conditions. For example, a soldier on the battlefield may perform their duty better when scared (or when not). Would the U.S. Military be justified in using fear as a motivator (or suppressing it entirely) for its soldiers? Would it be justified in using fear as a tool of war?
4. Quirk notes that the brain mechanism of fear learning is conserved across species with the amygdala, a subcortical region located in the medial temporal lobe, crucial as a node in fear circuitry. Why do you think, given nature’s variety, that its response to fear is so largely self similar?
5. Do you have phobophilia? The love of fear? Do you enjoy scary stories, haunted houses, darkened woods? Why would someone like fear in certain contexts?
6. Duke et al (1993) end by stating “[b]ecause fear resides within the individual, a manager must project beyond personal opinion about what fear issues are important and develop perspectives similar to those of other stakeholders to properly evaluate the effects of a fear appeal.” How can we develop (empathetic) perspectives for those whose fears we might never understand?
7. On the eve of the 2018 midterm elections, comedian Chelsea Handler remarked, “I think that fear works on both sides: […] I’m doing more than I’ve ever wanted to do in my entire life because I’m fucking scared shitless.”
8. Danis et al (2007) conclude that “[f]ear of retaliation from seeking ethics consultation is common among nurses and social workers, nonetheless this fear is not associated with reduced requests for ethics consultations.” Why does the fear for “doing the right thing” exist? 
9. “Fear,” Fairchild et al. (2018) tell us, “is now commonly used in public health campaigns” going on to examine how fear campaigns against the tobacco industry and HIV/AIDS epidemic began, evolved, and affected those involved. If fear can be used to improve the health of the populace, should the populace live in fear?
10. Should we be afraid?
11. “Professor Nobody” says that “Once awareness of the human predicament was achieved, we immediately took off in two directions, splitting ourselves down the middle. One half became dedicated to apologetics, even celebration, of our new toy of consciousness. The other half condemned and occasionally launched direct assaults on this gift.” Do you think that human predicament described – the “[m]adness, chaos, bone-deep mayhem, devastation of innumerable souls–while we scream and perish, History licks a finger and turns the page” of it all – has caused some fundamental shift in human consciousness?
12. “Fiction, unable to compete with the world for vividness of pain and lasting effects of fear, compensates in its own way. How? By inventing more bizarre means to outrageous ends.” Are their limits to which we should allow our art to induce fear?