Medical

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Regulatory

EHR: EHRA
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Articles and videos

CT screening flap leads to change in NEJM disclosure policy🆓 by Eric Barnes (January 13^th, 2003) ► The New England Journal of Medicine asks authors to reveal potential conflicts of interests.
Fed up hospitals defy patching rules🚫 by Ellen Messmer (July 9^th, 2004) ► Hospitals are angry to wait a long time for medical manufacturers to validate their software against the latest OS security patches.
Custom Solution Connects Doctors and Patient Data🚫 by Allison Proffitt (November 24^th, 2008) ► A project for collecting hepatitis C data in New Mexico is based on highly customisable forms so any participant can adapt the tool to his own needs.
Patent Rights and Civil Wrongs: The ACLU Lawsuit🚫 by Andrew W. Torrance (June 6^th, 2009) ► The ACLU challenges the fact that human genes and diagnostic methods are patentable.
Twittering Healthcare: Social Media and Medicine💰 by Mark Terry (August 2009) ► Some uses of Twitter for healthcare: physicians, hospitals, TrialX and CDC.
Handheld Mass-Spectrometry Pen Identifies Cancer in Seconds During Surgery — Simple device attaches to mass spectrometer to diagnose cancer by Emily Waltz (September 6^th, 2017) ► The title says it all.
AI’s chaotic rollout in big US hospitals detailed in anonymous quotes — Health care systems struggle with each step of AI implementation, study finds. by Beth Mole (May 3^rd, 2023) ► The summary of a study ("Organizational Governance of Emerging Technologies: AI Adoption in Healthcare") showing that healthcare entities have trouble exploiting Ai tools.
FDA
- Regulations and guidelines
  - Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application🚫 (August 2003) ► The FDA guidance for applying 21 CFR Part 11.
  - Medical devices
    - Medical Device Quality Systems Manual: A Small Entity Compliance Guide (December 1996) ► A guide for a small company’s Quality System.
    - Deciding When to Submit a 510(k) for a Change to an Existing Device🚫 by Susan Alpert (January 10^th, 1997) ► The title says it all.
    - Design Control Guidance For Medical Device Manufacturers -- This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001 (March 11^th, 1997) ► This guideline explains what are design controls.
    - Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices by Donna-Bea Tillman (September 9^th, 1999) ► The FDA guidance for systems containing OTS software.
    - General Principles of Software Validation; Final Guidance for Industry and FDA Staff by John F. Murray Jr. and Jerome Davis (January 11^th, 2002) ► The title says it all.
    - Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software by John F. Murray Jr. and David S. Buckles (January 14^th, 2005) ► The FDA guidance for handling security patches of off-the-shelf components.
  - Clinical trials
    - Guidance for Industry Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications🚫 (April 2006) ► The FDA guidance for clinical trials submissions.
    - Guidance for Industry - Computerized Systems Used in Clinical Investigations (May 2007) ► The title says it all.
    - Guidance for Industry - Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (May 2007) ► The title says it all.
- Warning Letters
  - Warning Letter: Rosenthal, Kenneth J., M.D. 11-Apr-05 (April 11^th, 2005) ► The investigator failed to maintain adequate records, to respect the protocol agreement, and to provide reports to the IRB…
- Application of FDA rules
  - Advantages to Risk-Based Validation — How to decrease computer-system validation time and costs🚫 by David Ade (May 2008) ► The FDA advocates a risk-based validation strategy.
- Janus
  - JanusDDQBDemo2🚫 (2006) ► A demo of IBM’s DDQB (Data Discovery and Query Builder) on Janus🚫.
  - JanuscaCOREPrototypeDemo🚫 (2006) ► A demo of caCORE on Janus.
- Evolution
  - U.S. FDA to add 1,300 staffers in big expansion🚫🆓 (August 1^st, 2008) ► FDA will hire 1300 persons, mainly for drug approval and postmarket vigilance.
  - eCTD: The First Nine Months🚫 by Ann Neuer (September 5^th, 2008) ► Still many eCTD submissions are improperly filled.
  - Sentinel Initiative Boosts FDA Safety Oversight🚫 by Ann Neuer (October 6^th, 2008) ► The FDA tries to create a tool for monitoring marketed medical products.
  - Trials Disclosure Clears Next FDAAA Deadline🚫 by Deborah Borfitz (October 27^th, 2008) ► Sponsors have now to report basic results on clinicaltrials.gov. Next year, they will also have to report adverse events.
- Controversies
  - New FDA Research Center Rife With Risks by Matthew Perrone (October 14^th, 2007) ► The creation of the Reagan-Udall Foundation and the issue of the FDA independence from the pharma industry.
  - Independent Testing and the FDA🚫 (January 30^th, 2008) ► The FDA review process is not properly done for medical devices, a review by an independent organisation may compensate this.
  - FDA denies it is risk-averse on drugs by Andrew Jack (March 26^th, 2008) ► Janet Woodcock, the head of CDER, denies that FDA is too afraid of taking risks when evaluating new drugs.
  - FDA, Facing Criticism, Bars Doctors From Drug Trials🚫 (June 6^th, 2008) ► FDA tries to be more effective at disallowing wrong-doing investigators to participate to other clinical trials.
  - FDA clears cardio devices on weak research: study by JoAnne Allen (December 29^th, 2009) ► Does the FDA approve too easily some medical devices?
HIPAA
- Protecting The Privacy of Patients' Health Information - Summary of The Final Regulation (December 20^th, 2000) ► An overview (from the patient’s point of view) of HIPAA.
- What takes precedence: HIPAA or state law? — In most cases, state laws will not be preempted by HIPAA by Jennifer Daw Holloway (January 2003) ► The most stringent law will have to be applied: HIPAA if it is more protective of patient’s privacy than the state law, the state law otherwise.
- More protections for patients and psychologists under HIPAA — HIPAA's psychotherapy notes provision safeguards sensitive patient information by Jennifer Daw Holloway (February 2003) ► The author describes how HIPAA applies to psychotherapy notes.
- Peddicord: New Privacy Concerns with ‘HIPAA 2’🚫 by Deborah Borfitz (January 4^th, 2010) ► Some new privacy and security requirements are part of American Recovery and Reinvestment Act.
- The Reality of Medical Software Compliance🚫 by Kent Matthies (January 19^th, 2010) ► Some advice to healthcare providers in order to be compliant with the HITECH Act.
China
- Ex-Chief of China Food and Drug Unit Sentenced to Death for Graft by David Barboza (May 30^th, 2007) ► China’s FDA chief gets sentenced to death penalty for accepting some bribes!
India
- Regulatory Changes Afoot in India🚫 by Deborah Borfitz (November 24^th, 2008) ► India will change its regulations for phase 1 clinical tests of molecules created in other countries.
Electronic health record
- Visualizing Electronic Health Records With "Google-Earth for the Body" — IBM researchers develop 3-D visualization tool for electronic health records by Robert N. Charette (January 1^st, 2008) ► IBM has created a 3D visualisation to help navigate the patient’s EHR.
Personal health record
- New Frontiers in PHRs🚫 by Stephen Barlas (September 23^rd, 2008) ► The PHR market is taking off.
Genomics
- Predicting Dose Response🚫 (September 13^th, 2007) ► Genetic testing would help dosing warfarin.
- The DNA Data Deluge🚫 (April 1^st, 2008) ► DNA sequencing is generating huge amounts of data, how can this data be managed?
- FDA Warms to Pathway Tool Use🚫 (May 12^th, 2008) ► FDA expects that its VXDS (Voluntary Exploratory Data Submissions), after being successful with microarray processing techniques, will give similar results with pathway tools.
- You've Got Email — A Human Genome🚫 (January 30^th, 2009) ► Genome sequences can be better compressed by recording only the differences to a reference genome.
- Eric Lander Reviews “Breathtaking” Advances in Genome Sequencing🚫 (February 5^th, 2009) ► Eric Lander’s speech on the future of sequencing.
- Pinpointing a Perfect Pitch Gene🚫 (August 13^th, 2009) ► Jane Gitschier is looking for the absolute pitch gene.
- The Genome Question: Moore vs. Jevons with Bud Mishra↓ by Bud Mishra (March 27^th, 2012) ► The issue of the data deluge, the fact that genomics failed to deliver what we expected from it, and some proposed solutions.
- Human Genetics and Genomics: The Science for the 21st Century by Ewan Birney (July 12^th, 2012) ► A presentation trying to motivate software engineers to work in the field of genomics.
- Personal genomics
  - Personal Genomics Companies Rush to Comply with California Regulations🚫 (June 18^th, 2008) ► Regulators are looking to personal genomics companies.
  - 23andMe
    - Googling the Googlers' DNA: A Demonstration of the 23andMe Personal Genome Service Using Three Relatively Well Known Googlers as Illustrative Examples by Linda Avey (May 7^th, 2008) ► This presentation seems to be the same as the one reported in the next article.
    - 23andMe: Avey Proposes New Personal Genomics Paradigm🚫 by Kevin Davies (May 13^th, 2008) ► A summary of Linda Avey, co-founder of 23andMe, presentation of her company at Bio-IT World Expo.
  - deCODEme
    - Software Glitch Scrambles Personal Genomics Data🚫 by Kevin Davies (August 27^th, 2009) ► A journalist found a bug in deCODEme presentation software.
HL7
- HL7 RIM: An Incoherent Standard by Barry Smith and Werner Ceusters (August 2006) ► The authors criticise RIM for mixing the information model (how the IT models the healthcare world) and a reference ontology (the model of the healthcare world itself).
- ↪The HL7 Reference Information Model Under Scrutiny by Gunther Schadow, Charles N. Mead, and D. Mead Walker (2006) ► The authors answer to several criticisms on RIM: RIM violated UML; the information model / reference ontology mix (this is the previous article); speech acts not encoding the act itself, being attributed, and having no "continuants".
- HL7 101: A Beginner’s Guide by Dave Shaver (February 26^th, 2007) ► A high-level introduction to HL7 history and purpose.
Theranos
- The Theranos Scandal Is Just The Beginning — There will be more companies like Theranos in our future. by Christina Farr (May 10^th, 2016) ► Investors, who have no clue about biotech, will continue to dumbly put money in dubious startups.
- Elizabeth Holmes sentenced to 11.25 years in prison for Theranos fraud — Holmes is expected to appeal. by Beth Mole (November 18^th, 2022) ► Almost the end of the story, but Elizabeth Holmes will appeal her conviction.