Project Management and the Professional
This is an individual assignment
Comment
Technology development is occurring swiftly. In particular, the Internet’s ability to access, capture and make available information has prompted a range of small paid applications (apps) to be developed for mobile devices. These can allow everything from checking the weather to gambling on games of chance – all without leaving your seat. The commercial value is obvious but sometimes the accuracy and ethics behind certain types of apps is unclear. In fact, one could say that Internet mobile technology (and its potential for use/misuse) has been growing faster than either the law or ethics have been able to match.
Background
In this assignment you will discuss the ethics of a real-life situation as reported in the public domain (see the attached case study). It concerns the commercial development and sale of medical apps to customers who can then provisionally self-diagnose health conditions as an alternative to seeking consultation with a licenced medical practitioner. As a project management student who in future mayhelp develop apps (or have privileged access to information provided by their use) such issues could be quite relevant to your long-term roles and activities within the technology sector.
While the original text for the attached case study can be found in the references provided at the end, you are also expected to further research the topic for yourself.
Tasks and Assessment
This assessment requires that you prepare a report in three parts, answering all of the following questions in each section. You are expected to conceptualise the problem or issue, find relevant references for context, facts, theory and examples and come up with appropriate points of view. Your positions should be supported with argument and citations as appropriate. Marks will also be awarded for presentation and professionalism of the response.
1) Stakeholder Ethics (6 marks)
a) Identify at least 3 key stakeholders relevant to this case study. For each key stakeholder describe the situation and reasoning from their perspective.
b) Explain the major areas of conflict, if any, between these perspectives.
c) For each stakeholder group identified, select what you believe is the relevant ethical view taken (e.g. Deontology, Consequentialism, Relativism, Universalism, Virtue Ethics, Justice Ethics, Ethical Pluralism, etc.). Explain your answer.
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2) International Codes of Ethics (6 marks)
Many could potentially be affected by the actions of those developing mobile apps for commercial use. Research the ethics and codes of conduct for Information Technology industry bodies representing Australia (e.g. Australian Computer Society (ACS)) plus two other nations or international groups (e.g. Association for Computer Machinery (ACM), Institute of Electrical and Electronics Engineers (IEEE), British Computer Society (BCS), Computer Society of India (CSI), Institute of IT Professionals, New Zealand (IITP), etc.).
Answer the following questions:
a) What evaluation would each Code likely render on the case study situation described? Which (if any) position would the Codes most likely support? Supply clear reasoning for both these points.
b) What are the major differences (if any) between the three ethical codes of conduct you have reviewed in relation to the case study situation? Justify your answer with specific references to items within both the case study and the Codes themselves.
3) Subjective Code of Ethics (6 marks)
a) What do you personally think of the circumstances described in the case study? Explain your own individual ethical viewpoint in regard to the situation outlined and give your personal assessment of stakeholder groups involved. Are they justified in their points of view?
b) Nominate at least 3 other ethical/legal issues that you see potentially arising from the spread of Internet/technology use and the ability to make information widely available. Explain why these are now, or could become, problems.
Additional: Report Presentation and Standard of Work (2 marks)
The report should be written as if for a professional audience and not just as an attempt to satisfy an academic course requirement. It should communicate clearly, exhibit attention to detail and present to a high standard, including:
? Title page (student number, name, tutor name, tutorial number, report title) – in addition to the FEIT cover sheet properly filled in;
? Executive summary, table of contents, page numbers, heading numbers, etc.;
? Headings for assignment sections plus short Introduction and Conclusion sections;
? Appropriate use of quotes and diagrams (where applicable);
? Assertions and statistics backed up by properly cited sources where needed;
? Correct Harvard/UTS referencing;
? Correct length – deals fully/appropriately with each topic without verbosity;
? Report clarity – including depth of analysis and correct English expression/spelling.
Note (repeating students only): If you have previously attempted 31272 you may re-use your assignment 1 mark from that time. If so, you MUST email the Subject Coordinator with your Student Id and previous semester by 5pm, 27 March 2015. Return confirmation should be kept. Failure to obtain written confirmation by the nominated date means this current assignment is to be undertaken as normal.
Report Submission
Referencing Standards
All material derived from other works must be acknowledged and referenced accordingly using the Harvard/UTS Referencing Style. For more information see:
http://www.lib.uts.edu.au/help/referencing/harvard-uts-referencing-guide
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Late Penalty
Late submission of the assignment will attract a penalty per the Subject Outline. Special consideration for late submission must be arranged beforehand with subject co-ordinator.
Reminder
Students are reminded of the principles laid down in the “Statement of Good Practice and Ethics in Informal Assessment” (in the Faculty Handbook). Unless otherwise stated in a specific handout, all assessment tasks in this subject should be your own original work. Any collaboration with another student (or group) should be limited to those matters described in “Acceptable Behaviour” section of the Handbook. For essay questions, students should pay particular attention to the recognition of “Plagiarism” as described in that section of the Handbook. Any infringement by a student will be considered a breach of discipline and will be dealt with in accordance with Rules and By-Laws of the University. Penalties such as zero marks for assignments or subjects may be imposed.
Improve Your Academic and English Language Skills
HELPS (Higher Education Language and Presentation Support) Service provides assistance with English proficiency and academic language. Students needing to develop their written and/or spoken English can make use of the free services offered by HELPS, including academic language workshops, vacation courses, drop-in consultations, individual appointments and Conversations@UTS (www.ssu.uts.edu.au/helps). HELPS is located in Student Services, on level 3 building 1 City campus and the Student Services area at Kuring-gai campus. Phone 9514-2327 or 9514-2361.
The Faculty of Engineering and IT intranet (MyFEIT):
http://my.feit.uts.edu.au/myfeit)
and Faculty Student Guide: http://my.feit.uts.edu.au/modules/myfeit/downloads/StudentGuide_Online.pdf
provide information about services and support available to students within the Faculty.
Useful Hints for This Assignment
1. ACS code of ethics and code of professional conduct can be found at:
http://www.acs.org.au/about-the-acs/member-conduct-and-discipline
2. The UTS Library on-line Journal Database may help with your research. It is accessible from http://www.lib.uts.edu.au/databases/search_databases.py. You need to activate your UTS e-mail account (http://webmail.uts.edu.au/ ) in order access the resource through out-of-campus facilities.
3. The Executive Summary summarises the report’s findings and recommendations. It can stand by itself as an overview of your ideas. Write it last. In contrast, an Introduction tells the reader what the report is going to cover.
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Assignment 1 Case Study
These Medical Apps Have Doctors and the FDA Worried By Robert McMillan 29 July 2014
Iltifat Husain has seen an awful lot of sickness and injury during his time as an emergency room doctor, but lately, he’s worried about something new. He’s worried about the ill effects of mobile healthcare apps.
There are hundreds of medically themed apps in Apple’s App Store and Google Play, and by most accounts, they’ve been wonderful tools for tracking, evaluating, and taking control of our personal health. Husain loves apps such as Draw MD, which lets physicians draw out surgical procedures for patients, and MicroMedex, a prescription drug reference encyclopedia. But he’s concerned about the emergence of untested apps that are marketed as replacements for legitimate medical equipment—apps such as Instant Blood Pressure, which purports to take your blood pressure by way of the iPhone.
According to Husain, a faculty member in the Emergency Medicine department at the Wake Forest University School of Medicine, these apps could very well land someone in his E.R.—and maybe even get them killed.
He’s not alone in his concern. With an editorial in The New England Journal of Medicine last week, Nathan Cortez, an associate professor of law at Southern Methodist University Dedman School of Law in Dallas, Texas, called attention to this problem, and you’ll hear much same complaint from Eric Topol, a medical doctor and director of the Scripps Translational Science Institute. “These apps have no validated data compared with accepted reference standards and therefore are quite concerning,” he says.
Although Husain believes these apps could be seriously harmful, the good news is that the FDA says it is now working to crack down on questionable healthcare apps, and some app makers may be willing to provide additional disclosures about their software when pushed to do so.
To illustrate his concern, Husain points to Instant Blood Pressure, which claims it can take a blood pressure reading in under a minute “using only your iPhone—no cuff
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required.” The $3.99 app has been among the top 30 most-downloaded apps in the Health and Fitness section of the App Store for the past few weeks, and it features several glowing reviews. According to the app’s description, it “uses a patent-pending process developed by a team from the Johns Hopkins University—a world leader in health innovation.”
Screenshot: WIRED
The problem is that doctors like Husain have no reason to believe it actually works. There is no public research explaining how the app operates, and the company hasn’t done the kind of study that the Food and Drug Administration would require in ordered to get Instant Blood Pressure cleared as a medical device.
We contacted Johns Hopkins about the app, and they told us that it is not affiliated with the university and that they were sending the app’s maker, Aura Labs, a cease-and-desist letter demanding that they stop using their name. Husain is worried that someone might put off necessary medical treatment because of bad data obtained from an app like this. Based on the App’s reviews, at least some of the users believe that they’re getting accurate blood pressure measurements from the app. “Reading these comments is harrowing,” Husain says. “It’s like: ‘Oh my god, people are actually using this stuff and thinking it’s real.’”
According to Husain, they could very well land someone in his E.R.—and maybe even get them killed.
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To use Instant Blood Pressure, you download the app, press your phone against your chest, and put your index finger against the camera, and in less than a minute, it gives you a reading. I tested the app and got a 125 over 66 reading with a heart rate of 55 beats per minute. Then, after two misfires, where the app couldn’t get a reading and told me to try again, it recorded 121 over 65, with a much higher heart rate of 74. At no time did the app itself warn me of its untested and potentially unreliable nature. In fact, if I hadn’t scrolled down to its App Store description, and clicked “more,” I would never have seen the company’s warning that the software is for recreational use only and is “not an FDA cleared medical device.”
The App Store description for Instant Blood Pressure, which doesn’t clarify that it’s not an FDA-cleared device until you click ‘more’. Screenshot: WIRED
There’s another app, called Instant Blood Pressure Pro that makes identical claims to Instant Blood Pressure. The app’s support page appears to be inactive and provides no way to contact its maker, Mini Touch. Its lone customer review begins: “You could kill somebody.”
Like other similar apps in the App Store, Instant Blood Pressure contains a disclaimer that it is for “entertainment purposes only,” but this disclaimer is not immediately
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visible when you look at the App in Apple’s store or Google Play. But there is a more prominent warning on the app’s website.
A third app, called Pulse Oximeter Pro, claims to be able to measure “blood oxygen saturation without peripherals.” Clicking on its support page link takes you to an Arabic-language gaming site. Yet another product, Pulse Oximeter, contains a similar, hard-to-find disclaimer, but connects to a legitimate product support site. That kind of buried caveat is simply not good enough, given the risks of medical harm here, says Topol. “The disclaimers are grossly inadequate; consumers don’t read this buried information.”
Pulse Oximeter’s creator, a Norwegian family medicine doctor named Damoun Nassehi, told us that he plans to add new warnings in an upcoming version of the app. And that’s a good thing. According to Nassehi, his app is not always consistent and should not be used for real medical data-gathering. “It is meant to be used by adults in recreational setting,” he says.
‘Our typical approach would be to allow a firm to come into compliance voluntarily before taking enforcement action.’
The FDA would not comment on any specific app, but in an email, Jennifer Rodriguez, an agency spokesperson, told us that “the FDA is focusing on a small subset of mobile apps that are medical devices and present the greatest risk to patients if they do not work as intended. For that subset, the FDA might take action were it to determine that an app does not meet relevant regulatory requirements. But our typical approach would be to allow a firm to come into compliance voluntarily before taking enforcement action.”
Instant Blood Pressure’s maker, Aura, company didn’t respond to multiple requests for comment. But Husain claims that the company’s CEO, Ryan Archdeacon, wouldn’t tell him how the app worked. “He was very straightforward with telling me that he could not explain how the app works—basically stating how it’s a patent-pending process that he can’t get into at all,” Husain wrote in a blog post about the app.
Now that the FDA is investigating, it will most likely work with app makers to ensure that they post adequate warnings on their unproven software. When products like these are intended to measure vital signs, they need to first be cleared by the FDA
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before they can be sold in the U.S., says Christopher Rush, a former FDA investigator who is now president of FDA Quality and Regulatory Consultants. And with these “recreational” medical apps, the FDA is going to take steps to ensure that consumers aren’t misled into using them for medical advice. “They’re going to ask the software developers to stop selling it until they get those warnings in place,” he says. If that doesn’t work, the FDA will most likely go straight to Apple and Google and ask them to pull the apps.
***
Original reference:
http://www.wired.com/2014/07/medical_apps/
Related References:
http://www.smh.com.au/digital-life/digital-life-news/risks-feared-in-medical-apps-20140129-31le8.html
http://www.smh.com.au/digital-life/smartphone-apps/patients-who-use-health-apps-stay-healthier-20140728-zxpdp.html
http://www.stuff.co.nz/technology/digital-living/60452414/Experts-warn-over-use-of-health-apps
http://lifescientist.com.au/content/biotechnology/article/the-rise-of-smartphone-health-and-medical-apps-1072193834
http://www.ctsguides.com/medical/medical-apps-security/
http://www.medscape.com/viewarticle/763009_2
http://www.informationweek.com/mobile/11-super-mobile-medical-apps/d/d-id/1105143
http://www.bcmj.org/newsnotes/health-e-apps-project-encourage-effective-use-mobile-health-applications