Should patients access data of medical devices or softwares?
This is an absolutely timely topic and I’ve just recently come across pretty relevant news and articles focusing on whether patients should get access to source codes and data provided by their implantable devices. A few examples:
Hugo Campos has a small computer buried in his chest to help keep him alive. But he has no idea what it says about his faulty heart.
All the raw data it collects, especially any erratic rhythms it controls with shocks, goes directly to the manufacturer. And some of it later gets sent to his doctor.
Lawyer Karen Sandler’s heart condition means she needs a pacemaker-defibrillator to avoid sudden death, so she has one simple question: what software does it run?
Yet it turns out that it’s impossible for her to see and understand the technology that’s being installed into her own body and upon which her life depends. Regulatory authorities don’t see or review the software either.
My two cents here? They DO have access to any kind of data related to their health. But what do you think?
Berci, thank you for sharing. You wrote, that patients do have access to any kind of data related to their health. Hugo Campos, does not have access to his data generated by his ICD, and it looks like device manufacturers will have to include the patient in their future solution developments. Could you explain me, what you meant by that?
Next to the question of giving access, we should ask ourselves the question who owns that data? As the real value is not be giving access to data generated by one source, but by aggregating the data from different sources, looking for patterns, and developing algorithms that sent out early warnings, creating clinical alerts from patients and doctors, allowing them to make better decisions. Just like we did in Toronto.- http://www-03.ibm.com/press/us/en/pressrelease/24694.wss
There is no good answer for that. We see the same kind of problem in genomics (who owns the data of my genome?).