News from Germany: Organ Transplantation and “Research Donations”
On May 25, 2012, theParliament of the Federal Republic of Germany ( “Deutscher Bundestag”) passed “The Act to amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”,BT-Drs. 17/9773) and “The Law to Regulate the Opt-In Solution for Organ Transplantation” (BT-Drs. 17/9774, BT-Drs. 17/9030). Only a couple of weeks later, on June 15, 2012, theBundesrat (one of the German constitutional bodies) has acknowledged both acts (Art. 77, 78 of the German Constitution). According toArt. 50 of the German Constitution, the federal states participate in the legislation and administration at a federal level and in matters c...
Source: PredictER Blog - August 2, 2012 Category: Medical Ethics Authors: Anonymous Source Type: blogs

News from Germany: Organ Transplantation and “Research Donations” – Round 2?
On July 21, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr finally signed the “The Act to Amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”.  It is published in theFederal Law Gazette Number 1, BGBl. I 35/2012, p. 1601 and became effective on August 1, 2012. The act has been described here atPredictER News, July 20, 2012.From day one, the act has had its critics, in large part, because of the organ transplantation scandal uncovered at the University of Goettingen (Germany) in June 2012.  An organ transplantation specialist ...
Source: PredictER Blog - August 2, 2012 Category: Medical Ethics Authors: Anonymous Source Type: blogs

Waiting for November 2012 and the Final Verdict on Br üstle v. Greenpeace e.V.
The GermanFederal Court of Justice ( “BGH”) finally announced that it will decide in the case Brüstle v. Greenpeace e.V. on November 27, 2012.The case was described and discussed here atPredictER News, December 13, 2012 andJune 11, 2012. The court will adjudicate more than two years after it requested preliminary ruling from the European Court of Justice (ECJ) on December 17, 2009 (Case Xa ZR 58/07, now changed to X ZR 58/07), and a year after the ECJ ’s decision inCase C-34/10 regarding the interpretation of Art. 6 of the Directive 98/44/EC on October 18, 2011.The BGH ’s decision will not only influence the question of wh...
Source: PredictER Blog - June 20, 2012 Category: Medical Ethics Authors: Anonymous Source Type: blogs

Waiting for November 2012 and the Final Verdict on Br ĂĽstle v. Greenpeace e.V.
The German < a href= " http://www.bundesgerichtshof.de/EN/Home/home_node.html " target= " _blank " > Federal Court of Justice < /a > ( “BGH”) finally announced that it will decide in the case Brüstle v. Greenpeace e.V. on November 27, 2012. < br / > < br / > The case was described and discussed here at < a href= " http://predicter.blogspot.com/2011/12/end-of-embryonic-stem-cell-research-in.html " > PredictER News, December 13, 2012 < /a > and < a href= " http://predicter.blogspot.com/2012/06/what-happened-after-european-courts-of.html " > June 11, 2012 < /a > . The court will adjudicate more than two years after it...
Source: PredictER Blog - June 19, 2012 Category: Medical Ethics Authors: PredictiveHealth EthicsResearch Source Type: blogs

What happened after the European Courts of Justice decision Br üstle v. Greenpeace e.V.?
More than six months after the European Court of Justice (ECJ) decided Br üstle v. Greenpeace e.V. (Case C-34/10) on October 18, 2011 (which was described and discussed here atPredictER News, December 13, 2012), theGerman Federal Court of Justice (BGH) has still not made its decision. What happened after the October decision?Only a couple days after the decision had been made, several representatives of the European Parliament filed a request to the EU Commission to stop the funding of embryonic stem cell research in the EU program,Horizon 2020 (EPP Group in the European Parliament). In their point of view, the ECJ decisio...
Source: PredictER Blog - June 11, 2012 Category: Medical Ethics Authors: Anonymous Source Type: blogs

What happened after the European Courts of Justice decision Br ĂĽstle v. Greenpeace e.V.?
More than six months after the European Court of Justice (ECJ) decided Br ĂĽstle v. Greenpeace e.V. ( < a href= " http://curia.europa.eu/juris/document/document.jsf?docid=111402 & amp;doclang=en & amp;mode= & amp;part=1 " target= " _blank " > Case C-34/10 < /a > ) on October 18, 2011 (which was described and discussed here at < a href= " http://predicter.blogspot.com/2011/12/end-of-embryonic-stem-cell-research-in.html " target= " _blank " > PredictER News, December 13, 2012 < /a > ), the < a href= " http://www.bundesgerichtshof.de/EN/ " target= " _blank " > German Federal Court of Justice < /a > (BGH) has still not mad...
Source: PredictER Blog - June 10, 2012 Category: Medical Ethics Authors: PredictiveHealth EthicsResearch Source Type: blogs

The Next Ethical Problem in Translational Science: Crossing the " Policy Valley of Death " . Eric M. Meslin, PhD. Nov. 14th, 2011
Join us Monday, November 14th at 3:00 p.m. for a presentation by Eric M. Meslin, < i > The Next Ethical Problem in Translational Science: Crossing the " Policy Valley of Death " < /i > . Location: Indiana University Center for Bioethics, 410 West 10th Street, Suite 3100, Indianapolis, IN. < br / > < br / > This presentation will make the case that there are two gaps to be bridged in successful translational science, one between " the bench and the bedside " and another between the " lab and legislature. " Without a sturdy bridge from the lab to the legislature, advances in translational science could be lost to the " pol...
Source: PredictER Blog - November 10, 2011 Category: Medical Ethics Authors: PredictiveHealth EthicsResearch Source Type: blogs

Mercy Health Plan's Medical Data Security Breach Should Inform OCR's Harm Standard
A recent < a href= " http://www.philly.com/inquirer/business/20101021_Medical-data_breach_said_to_be_major.html " > medical data security breach < /a > occurring in Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan in Philadelphia lends support to removing the harm threshold written into the < a href= " http://edocket.access.gpo.gov/2009/pdf/E9-20169.pdf " > Interim Final Rule < /a > of HIPAA and the HITECH Act before promulgating the Final Rule. In < a href= " http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/finalruleupdate.html " > August of 2009 < /a > , the Office of Civil Rights (O...
Source: PredictER Blog - November 9, 2010 Category: Medical Ethics Authors: Katherine Drabiak-Syed Source Type: blogs

California Department of Public Health Orders Changes to Berkeley's Genetic Test Program
Last week Berkeley altered its < a href= " http://onthesamepage.berkeley.edu/ " > Bring Your Genes to Cal < /a > Program to stop the genetic test results from being < a href= " http://onthesamepage.berkeley.edu/archive/2010-genes/release.php " > disseminated < /a > back to participating students in response to an order from the California Department of Public Health (CDPH). Berkeley will still hold discussions and lectures based on the aggregate information as previously planned. [See our posting on the Bring Your Genes to Cal Program < a href= " http://predicter.blogspot.com/2010/06/berkeley-scheduled-to-move-forward-wit...
Source: PredictER Blog - August 18, 2010 Category: Medical Ethics Authors: Katherine Drabiak-Syed Source Type: blogs

Judge Grants Partial Summary Judgment to Plaintiffs: Myriad's Gene Patents Are Invalid
On March 29, Judge Sweet issued a ruling in < a href= " http://news.justia.com/cases/featured/new-york/nysdce/1:2009cv04515/345544/ " > Association for Molecular Pathology v. United States Patent and Trademark Office < /a > . Known as the lawsuit against Myriad Genetics, this case was posed to answer the < a href= " http://www.nytimes.com/2010/03/30/business/30gene.html?adxnnl=1 & amp;ref=health & amp;adxnnlx=1269950809-ZvxVy0GnNJRAMLCvq49QtA " > widely debated < /a > question of whether human genes are patentable. In a 152 page < a href= " http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf " > ...
Source: PredictER Blog - April 4, 2010 Category: Medical Ethics Authors: Katherine Drabiak-Syed Source Type: blogs

Transparency of Texas ’ NBS Transfer and Reassessing Evasive Statutory Interpretation
A recentinvestigative reportfrom the Texas Tribune revealednew informationrelating to the sharing of newborn blood spots(NBS) in Texas.In November 2009, Texas Tribune reporters contacted the Texas Department of State Health Services (TDSHS) with a record request to review agency information and activities related to the NBS as permitted under the state ’s Sunshine laws. TDSHS refused, maintaining that the NBS records were confidential. After parties filed the settlement with the court, Texas Tribune inquired again to obtain the records and found that TDSHS transferred hundreds of de-identified NBS to the Armed Forces Insti...
Source: PredictER Blog - March 9, 2010 Category: Medical Ethics Authors: Katherine Drabiak-Syed Source Type: blogs

Transparency of Texas ’ NBS Transfer and Reassessing Evasive Statutory Interpretation
A recent < a href= " http://www.texastribune.org/stories/2010/feb/22/dna-deception/ " > investigative report < /a > from the Texas Tribune revealed < a href= " http://news.sciencemag.org/scienceinsider/2010/02/texas-supplied-newborn-blood-sam.html " > new information < /a > relating to the sharing of newborn blood spots < a href= " http://predicter.blogspot.com/2009/11/newborn-blood-spot-litigation-continues.html " > (NBS) in Texas < /a > . < br / > < br / > In November 2009, Texas Tribune reporters contacted the Texas Department of State Health Services (TDSHS) with a record request to review agency information and activi...
Source: PredictER Blog - March 8, 2010 Category: Medical Ethics Authors: Katherine Drabiak-Syed Source Type: blogs