1. Bioelectronics, Medical Imaging and Our Bodies Week 2: Data ownership (cardiac pacemakers and more) Maryse de la Giroday 6-week course SFU Liberal Arts & Adults 55+ program

2. Maryse de la Giroday Largest, independent, science blog in Canada Nanotechnology focus Technical writer, science writer, arts writer, marketing communications writer, etc. Founding member of Science Borealis One of two bloggers mentioned in Science Culture: Where Canada Stands (Council of Canadian Academies [RSC, CAE, and CAHS)

3. Maryse de la Giroday Mentioned in 3 rd edition of Digital Storytelling (Carolyn Handler Miller) MA (creative writing and new media); project: The Nanotech Mysteries (wiki) Have taught in the SFU writing program & elsewhere About to write a series on alternatives to animal testing for SEURAT-1 (EU project)

4. The big picture for Week 2: Data What is data Sea of data Memory Intellectual property Ownership (implants/tissues)

5. What is data? Scientific and/or medical information derived from experiments and clinical trials Name and address Heartbeats Tissue/blood/etc. Ones/zeroes Genetic code

6. Sea of data (1 of 3) Internet Archive (an internet library: https://archive.org/about/) Source: (https://www.techdirt.com/articles/20131112 /08225225212/internet-archive-fire-shows- vulnerability-worlds-digital-past.shtml) https://archive.org/about/https://www.techdirt.com/articles/20131112 /08225225212/internet-archive-fire-shows- vulnerability-worlds-digital-past.shtml The Internet Archive is the world's online memory, holding the only copies of many historic (and not-so-historic) Web pages that have long disappeared from the Web itself.

7. Sea of Data (2 of 3) [Internet Archive is] 2 petabytes of data and is currently growing at a rate of 20 terabytes per month. This eclipses the amount of text contained in the world's largest libraries, including the Library of Congress.

8. Sea of Data (3 of 3) At the end of President George W. Bush’s administration in 2009, NARA got roughly 35 times more data than from the Bill Clinton administration … With the federal government increasingly using social media, cloud computing and other technologies to contribute to open government, this trend is not likely to decline. By 2014, NARA is expecting to accumulate more than 35 petabytes (quadrillions of bytes) of data in the form of electronic records. (http://www.frogheart.ca/?p=5330 about data visualization)http://www.frogheart.ca/?p=5330

9. Losing your memory Luciana Duranti (from UBC in a 2006 interview): Alas, she says, every day something else is irretrievably lost. The research records of the U.S. Marines for the past 25 years? Gone. East German land-survey records vital to the reunification of Germany? Toast. A piece of digital interactive music recorded by Canadian composer Keith Hamel just eight years ago? “Inaccessible, over, finito,” says Duranti, educated in her native Italy and a UBC prof since 1987. Duranti is an expert panel member of the Memory Institutions and the Digital Revolution assessment

10. Keeping your memory Memory of the World UNESCO conference held in Vancouver in Sept. 2012 for archivists, records administrators, art historians, librarians, etc. Internet Archive had a fire in Nov. 2013 and lost some documents Dec. 2013 “Eighty per cent of scientific data are lost within two decades, according to a new study that tracks the accessibility of data over time.” Tim Vines, UBC (http://www.frogheart.ca/?p=12045)

11. Authenticity and trust (1 of 2) Trust and Authenticity in the Digital Environment: An Increasingly Cloudy Issue (Duranti; http://apalopez.info/ivcoindear/71duranti_pr es.pdf) June 4, 1989 Chinese search engines 2013

12. Authenticity and trust (2 of 2) The Cloud Return to 60s with dummy terminals and a mainframe... This time it isn’t the company mainframe, it is providers like Google, Microsoft or Amazon in whom we trust!

13. What is ownership? E-books Copyright Patents $$$ lost to current intellectual property system in US: The direct cost of actions taken by so-called “patent trolls” totalled $29bn (£18.5bn) in the US in 2011, (a study by Boston University)

14. Patent and copyright trolls People and/or entities which file patents and copyrights with the intention of filling suit at some time in the future for a financial payoff. Term also describes a type of behaviour: Blackberry (formerly RIM) was accused of trollish behaviour intended to paralyze competition

15. Patent thickets (1 of 6) Medical imaging (Patent Trolls and Technology Diffusion: The Case of Medical Imaging by Catherine Tucker ; http://papers.ssrn.com/sol3/papers.cfm?abstr act_id=1976593) http://papers.ssrn.com/sol3/papers.cfm?abstr act_id=1976593 Acacia is the seventh-largest patent-assertion entity in terms of its patent holdings, holding 536 patents in 2011.

16. Patent thickets (2 of 6) In September 2007, Hospital Systems Corporation, the newly-formed subsidiary of Acacia, launched a lawsuit in the Eastern District of Texas against GE Healthcare, Fujifilm Medical Systems, Siemens Medical Solutions, Philips Electronics and McKesson Corp (Case No. 2:07-CV-00389-TJW).

17. Patent thickets (3 of 6) The five defendants averaged 4,755 sales of different software components to hospitals. 163 software firms not targeted made an average of 138 sales of software components to hospitals. The five defendants responsible for just over half of all software sales in imaging software.

18. Patent thickets (4 of 6) Empirical analysis: a large reduction in sales of imaging software products relative to other similar products that were produced by the sued firms which didn’t fall under the scope of the disputed patent.

19. Patent thickets (5 of 6) No new variations of existing products or new models of imaging software from the sued vendors during litigation This lack of innovation may be due to the vendors’ fear of being found guilty of `willful infringement' in the patent suit and being held liable for treble damages.

20. Patent thickets (6 of 6) Phones: A rash of patent lawsuits has prompted the UN to call smartphone makers and others mobile industry bodies together. It said the parties needed to address the “innovation-stifling use of intellectual property” which had led to several devices being banned from sale. (http://www.frogheart.ca/?p=8240)

21. Who owns the data from your implanted medical devices? (1 of 9) Hugo Campos... wants access to data collected inside his body by an implanted cardiac defibrillator to help him take control of his [health &] figure out what triggers his frequent … abnormal heart rhythms which cause dizziness, fainting, and chest pain. (2011, Technology Review, http://www.technologyreview.com/news/426 171/getting-health-data-from-inside-your- body/)

22. Who owns the data from your implanted medical devices? (2 of 9) Campos is a self-quantifier – obtaining data on himself via wireless scales, – a Fitbit accelerometer, – a blood pressure cuff that can upload to his iPhone – a ZEO sleep tracking device. – & data when he feels an arrythmia to note what he was doing (or eating) when he experienced it (Jan. 2012 http://www.thedoctorweighsin.com/hugo- campos-fights-to-get-his-defibrillator-data/)

23. Who owns the data from your implanted medical devices? (3 of 9) Campos at TEDxCambridge (MA) https://www.youtube.com/watch?v=oro19- l5M8k (a little over 9 mins.) https://www.youtube.com/watch?v=oro19- l5M8k NPR show May 2012 (http://www.npr.org/blogs/health/2012/05/2 8/153706099/patients-crusade-for-access-to- their-medical-device-data)

24. Who owns the data from your implanted medical devices? (4 of 9) WSJ Nov. 2012 (includes video): (http://online.wsj.com/news/articles/SB100014 24052970203937004578078820874744076)http://online.wsj.com/news/articles/SB100014 24052970203937004578078820874744076 U.S. has strict privacy laws guaranteeing people access to traditional health files. But implants and other new technologies—including smartphone apps and over-the-counter monitors— redefine the concept of medical records.

25. Who owns the data from your implanted medical devices? (5 of 9) Medtronic says federal rules prohibit giving Ms. Hubbard's (another patient) data to anyone but her doctor and hospital. "Our customers are physicians and hospitals," said Elizabeth Hoff, general manager of Medtronic's data business. Medtronic needs regulatory approval to give patients data, she said. It hasn't sought approval because "we don't have this massive demand."

26. Who owns the data from your implanted medical devices? (6 of 9) Companies including Medtronic want to turn the data into money. Ms. Hoff said the company is contemplating selling the data to health systems or insurers that could use it to predict diseases and possibly lower their costs. At a July [2012] industry event, a senior Medtronic executive, Ken Riff, called these kinds of data "the currency of the future." (also in BC) In April [2012], Medtronic created Ms. Hoff's unit in part to look for business opportunities

27. Who owns the data from your implanted medical devices? (7 of 9) Device makers are in a race to design data-gathering implants. Medtronic and its rivals already collect heartbeats from more than one million people with defibrillators. St. Jude Medical Inc. is seeking approval for an implant that crunches numbers to help doctors and patients adjust medication levels. This would be new territory: Unlike, say, a defibrillator, the St. Jude implant doesn't deliver treatment itself. Instead, it simply gathers data to be used in making treatment decisions—such as whether a patient should increase medicine dosages.

28. Who owns the data from your implanted medical devices? (8 of 9) Some legal experts say 1996 U.S. law governing patient access to their health. the Health Insurance Portability and Accountability Act (HIPAA) hasn't kept up with technology. The law gives patients the right to access information held by doctors and hospitals. Raw data gathered by an implant isn't held by a doctor or a hospital: Typically it goes directly to the device maker, which provides a summary report to the doctor. And, Medtronic said, business agreements with doctors and hospitals restrict it to relaying information only to them.

29. Who owns the data from your implanted medical devices? (9 of 9) "Is the device itself a depository for medical records?" said Paul C. Zei, a cardiologist at Stanford University Medical Center … "Or is it part of the patient, and an extension of vital signs that we download into a medical chart?"

30. Monetary considerations What’s Hugo Campos profession? Are there any monetary considerations for Campos? What about memory & data? What about hacking & authenticity?

31. Who owns your tissue and blood? The Tissue-Industrial Complex (Rebecca Skloot) April 2006 NY Times Magazine (http://www.nytimes.com/2006/04/16/magaz ine/16tissue.html?pagewanted=all&_r=1&)http://www.nytimes.com/2006/04/16/magaz ine/16tissue.html?pagewanted=all&_r=1& John Moore Ted Slavin William Catalona Henrietta Lacks

32. Who owns your tissue and blood? (Moore, 1 of 9) John Moore in 1976 Surveyor on the Alaska pipeline David Golde, a prominent cancer researcher at U.C.L.A., said that removing his spleen was the only way to go. As Moore told the courts and the media, he signed a consent form saying that the hospital could "dispose of any severed tissue or member by cremation.

33. Who owns your tissue and blood? (Moore, 2 of 9) At 31 in 1976 & after the operation, Moore moves to Seattle & startd a new career. Flies to LA every few months to give samples of bone marrow, blood and semen Why not do this in Seattle? Golde starts paying for plane fares & hotel (Beverly Hills Wilshire) In 1983 (seven years after surgery) Moore gets suspicious when he’s given a consent form

34. Who owns your tissue and blood? (Moore, 3 of 9) "I (do, do not) voluntarily grant to the University of California all rights I, or my heirs, may have in any cell line or any other potential product which might be developed from the blood and/or bone marrow obtained from me." At first, Moore circled "do.“ "It's, like, you don't want to rock the boat," Moore told Discover magazine years later. "You think maybe this guy will cut you off, and you're going to die or something."

35. Who owns your tissue and blood? (Moore, 4 of 9) Next trip: Moore asked whether Golde was doing something commercial with his tissues. According to Moore, Golde said that U.C.L.A. would never do such a thing. But Moore circled "do not“ Eventually Moore contacts a lawyer & finds out: that weeks before giving Moore the first consent form, Golde filed for a patent on Moore's cells (the "Mo" cell line) and several valuable proteins those cells produced

36. Who owns your tissue and blood? (Moore, 5 of 9) Golde had entered into agreements with a biotech company that gave him stocks and financing worth more than $3.5 million to "commercially develop" and "scientifically investigate" the cell line. At that point, the market value of the Mo cell line was predicted to reach $3 billion.

37. Who owns your tissue and blood? (Moore, 6 of 9) Moore's cells special: – producing several valuable proteins used to treat infections and cancer and – carrying a rare virus that might lead to treatments for H.I.V.

38. Who owns your tissue and blood? (Moore, 7 of 9) Moore couldn't sell or donate tissue/blood/etc. because that would violate Golde's patent. Technically, you can't patent anything naturally occurring — like skin or blood. But once you alter something using human ingenuity, patents are fair game. Moore's cells wouldn't have survived outside his body unless Golde turned them into a cell line — self-perpetuating clones of one original cell. Hence the patent.

39. Who owns your tissue and blood? (Moore, 8 of 9) 1984 law suit filed against Golde & UCLA Moore was 1 st person to sue for profits and damages over tissue and blood Upset researchers hugely... If tissues excised from the body were the patient’s property then researchers who hadn’t gotten permission were guilty of theft, granting Moore & other patients rights would slow research

40. Who owns your tissue and blood? (Moore, 9 of 9) In 1990, Moore lost his case before the Supreme Court of California (excised tissue and blood is like garbage) Commercial value handed over to researchers. The effect has been to slow research.

41. Who owns your tissue and blood? (1 of 3) Ted Slavin is a hemophilliac exposed to Hepatiis B many times when blood banks didn’t check for diseases (1950s) Found out about his blood being rich with Hepatitis B antibodies in the 1970s Created a market for his own blood

42. Who owns your tissue and blood? (2 of 3) a multibillion-dollar product the Hep B test requires a steady supply of antibodies like Slavin's. Slavin needs money: would have attacks, become disabled, lose jobs. Contacts laboratories and companies asking if they wanted to buy his antibodies. They say yes

43. Who owns your tissue and blood(3 of 3) Cost of Slavin’s blood: $10/millilitre & up to 500 milliliters per order But Slavin also wants a cure for Hep B Baruch Blumberg

44. Who owns your tissue and blood? (Slavin/Moore) The difference between Moore & Slavin: information Slavin knew he had something valuable & established the terms for use of his blood before it left his body

45. Who owns your tissue and blood? (Catalona, 1 of 5) William Catalona, a top prostate surgeon in the world & a researcher Major court case over prostate tissue sample collection started in late 1980s by Catalona More than 4000 prostate samples & 250,000 blood samples from 36,000 men

46. Who owns your tissue and blood? (Catalona, 2 of 5) Catalona used the collection to prove the P.S.A. test can predict most prostate cancer got detailed consent forms & even sent out newsletters about research he was doing with the samples Washington University where Catalona worked had a different view on who owned the samples and had rights to it

47. Who owns your tissue and blood? (Catalona, 3 of 5) Washington University took possession of the samples The collection could be worth more than $15 million. In letters that surfaced in court, a Washington University official complained that Catalona gave free tissue samples to collaborators at a biotech company and that all the university gained in exchange for its support of Catalona was "the potential for Catalona to get a publication," which it saw as "unacceptable."

48. Who owns your tissue and blood? (Catalona, 4 of 5) Catalona’s contract with the university stated that they owned his intellectual property. University lawyers made an equivalency between intellectual property and the samples. Catalona quit & moved to Northwestern University. 6000 of his patients tried to have their samples moved to Northwestern

49. Who owns your tissue and blood? (Catalona, 5 of 5) Washington University refused to send the samples to Northwestern The 6000 patients then asked for their samples to be removed from the collection (based on the consent forms they signed) In Aug. 2003 Washington University sued Catalona In 2007 there was a ruling in the University’s favour

50. Who owns your tissue and blood? (Lacks, 1 of 3) Henrietta Lacks and HeLa cell line She died in 1951 (aged 31) Black, female, & a tobacco farmer She had cancer of the cervix Went to Johns Hopkins because it was the nearest hospital that would treat black people

51. Who owns your tissue and blood? (Lacks, 2 of 3) While Lacks was in treatment two samples (one healthy, the other not) were taken from her cervix with her knowledge Dr. George Otto Gey received her cells He found something extraordinary – Most cells die within days when excised from the body – Henrietta’s cells lived and continue to do

52. Who owns your tissue and blood? (Lacks, 3 of 3 Henrietta Lacks’ cells are immortal & instrumental: – the polio vaccine, cloning, gene mapping, in vitro fertilization, and more – bought and sold by the billions – Meanwhile her family couldn’t afford healthcare (prior to Obamacare?) August 2013, an agreement by the family and the National Institutes of Health gave the family some control over access to the cells' DNA code & a promise of acknowledgement in scientific papers. Also, 2 family members to join a six-member committee to regulate access to the code The immortal life of Henrietta Lacks (Rebecca Skloot’s book)

53. Genes (1 of 5) US (Myriad Genetics, BRCA1 and BRCA2 [human breast cancer susceptibility genes], & the Supreme Court) – June 14, 2013 Supreme Court ruled no one can get a patent on gene that’s been snipped out – After ruling Myriad starts suing competitors (in Utah) (http://www.huffingtonpost.com/sandra- park/myriad-genetics-latest-at_b_4949641.html)http://www.huffingtonpost.com/sandra- park/myriad-genetics-latest-at_b_4949641.html

54. Genes (2 of 5) Canadian researchers were at the forefront of mapping genes researchers from McGill and Laval collaborated with the researcher who founded Myriad (some of Myriad’s intellectual property based on research done on the Cdn.public dime) In 1995 the McGill researchers refused to be part of the Myriad patent & started working with UK collaborators

55. Genes (3 of 5) Patent chill (test costs haven’t gone down) In Canada: 2000/1 there was a big fight and the provinces banded against Myriad which withdrew but – the company could return to Canada – (http://www.cbc.ca/news/health/breast-cancer- gene-patents-the-canadian-story-1.1338883)

56. Genes (4 of 5) Richard Gold (McGill Law School) in the Globe & Mail (http://www.theglobeandmail.com/globe- debate/us-says-no-to-gene-patents-now- canada-must-decide-and- quickly/article12550334/)http://www.theglobeandmail.com/globe- debate/us-says-no-to-gene-patents-now- canada-must-decide-and- quickly/article12550334/ Expresses concern that legislation in Canada does not discuss genes & that investors will get nervous

57. Genes (5 of 5) Sept. 5, 2014 Australia’s federal court rules it will allow gene patents as per BRCA1 (Myriad won its case in Australia) http://www.abc.net.au/lateline/content/2014 /s4082258.htm) http://www.abc.net.au/lateline/content/2014 /s4082258.htm Luigi Palombi (Australian lawyer): high costs of BRCA1 and BRCA2 tests in US because of patents

58. Canadian tissues (1 of 6) In Ontario, as of June 2014, institutions own your tissue when removed from your body (http://news.nationalpost.com/2014/06/05/h uman-tissue-removed-for-medical-tests-is- personal-property-of-institution-not-person- it-came-from-ruling/)

59. Canadian tissues (2 of 6) “Traditionally, Canadian law has held that patients retain an ongoing interest in personal health information, no matter where it resides. We have long had a right to control what is done with information that comes from our bodies because, to quote a famous Supreme Court of Canada decision on point, “[i]t is information that goes to the personal integrity and autonomy” of the individual.” (Caulfield)

60. Canadian tissues (3 of 6) Timothy Caulfield – (http://www.theglobeandmail.com/globe- debate/who-owns-your-tissue-youd-be- surprised/article19256582/)http://www.theglobeandmail.com/globe- debate/who-owns-your-tissue-youd-be- surprised/article19256582/ Decision does not have precedent setting weight & covers a narrow procedural matter

61. Canadian tissues (4 of 6) “… human cells are no longer just anonymous globs of biomaterial. We should now think of every cell as a repository of a whole bunch of highly personal health information. Indeed, this is one reason tissue is such a valuable research resource. They are tiny filing cabinets filled with our genetic story.”

62. Canadian tissues (5 of 6) Caulfield’s research: A 2012 survey of more than 1,000 Albertans, for example, found – 26% thought the individual retained ownership of human tissue donated for research purposes, – 23% thought the researcher did and – 44% thought the research institution.

63. Canadian tissues (6 of 6) “We also asked provincial privacy commissioners and legal and bioethics experts. The majority of respondents from these three communities thought the individual, the source of the tissue, continued to own and control the donated tissue samples. However, 77 per cent of scientists believed ownership rested with the research institution.”

64. BC & data Alan Cassals (Sept. 2014 issue of Common Ground) Argument is that BC should open up its health data to private business Data effects/open data Many wild claims about jobs & economic benefits (cost savings of $2B) e.g. Canada’s Open Data Pilot Project (http://www.frogheart.ca/?p=3145 2011)http://www.frogheart.ca/?p=3145

65. Summary of Week 2: Data What is data Sea of data Memory Ownership (implants/tissues)