Medical Device Software Verification, Validation and Compliance

About a century ago, Dean John Wigmore, Northwestern University School of Law, hypothesized that if “there is ever devised a psychological test for the valuation of witnesses, the law will run to meet it.” But his prophesy has yet to prove itself. In fact, it often seems that the law has been running away from the polygraph. In his new book, Ken Blackstone explains that this has less to do with the validity of the polygraph and more to do with the lack of a bright line between forensic and utility polygraph.

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Several years ago, cardiologist Bob Carey, M.D., decided he wanted his grandchildren to understand how much he had learned over his 56-year career not from his colleagues or from medical school but from his patients and their caregivers. “I wanted to share their kindness and courage,” he explains. “I wanted to write stories about my patients so my 12 grandchildren could learn from them as I had.” His daughter shared what he had written to an author who encouraged Bob to realize a book. Now Dr. Carey’s dream has finally come true! “Patients Teach a Doctor About Life and Death: Tales from Fifty-Six Years of Practicing” is a compendium of detailed and inspiring personal vignettes culled from Bob’s experiences over half a century. Beginning with his early years at Boston University Medical School’s main teaching hospital (now called Boston Medical Center) in the early 1950s, Bob’s book recounts the story of his treating his very first patient, Gladys: “a tall lady with enlarged lymph nodes in her neck” originally diagnosed with Hodgkin’s disease. Though ultimately dying from heart disease and kidney failure, Gladys remained Bob’s patient for nearly two decades, teaching Bob that “one can never be absolutely certain of a person’s ultimate prognosis.” This lesson stayed with him throughout his many years of practice. After the initial introduction, “Patients Teach a Doctor About Life and Death” is divided into sections that describe his years in medical school, his military service in Okinawa, his years of medical residency as well as private practice, family experiences, time in China and extensive pro-bono work in South America. Each section conveys heartwarming stories from Dr. Carey’s unique point of view. A fellow doctor and friend R.A. Macdonald testifies that Bob’s book is the story of a doctor “who is a product of a largely bygone era… A time when doctors actually listened to their patients.” An absorbing read, “Patients Teach a Doctor About Life and Death” has much to say about how relationships work between doctors and patients from a medical standpoint as well as teaching us how curiosity and compassion play into successful outcomes. Proceeds of the book are being donated to a foundation established by Bob to provide scholarships for medical students to work with doctors in poor countries. Born in Arlington, Massachusetts in 1929, Bob Carey is a graduate of Harvard College and Boston University School of Medicine. In 1954 he married his high school sweetheart, Mary O’Neill, and the two went on to raise five children. In 1960 he joined a practice in Arlington, and later helped found Internist Inc., a group practice, in 1970. This practice joined Lahey Clinic in 1993 until Bob officially retired from medical practice in 1998. Since then, he has been teaching at BU and Harvard Medical School, and volunteering annually for pro bono medical service in Bolivia and Ecuador.

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