FDA Power Grab
As health-care providers computerize how they take care of us, we’re computerizing how we take care of ourselves—and how we connect back to our doctors. There are apps for managing our prescriptions, tracking blood sugar, and monitoring pacemakers or pregnancies. These tools are critical to breaking the chokehold that paperwork, waiting rooms and endless process have on medicine…
The FDA wants to regulate software used to support the decisions made by patients and health-care providers in the same way it regulates the software embedded in medical hardware such as X-ray machines and infusion pumps. But existing regulations don’t fit the new kinds of apps that developers are making, such as portable health records and programs that let doctors and patients keep track of data on iPads. Some 62% of physicians are now using tablets at the point of patient care…
The FDA’s approach to health-information technology risks snuffing out activity at a critical frontier of health care. Poor, slow regulation would encourage programmers to move on, leaving health care to roil away for yet another generation, fragmented, disconnected and choking on paperwork.
Source: WSJ editorial by Scott Gottleib and J.D. Klienke.
The manufacturers of software used to support clinical decision making already face liability if they design the software’s critical path decision tree incorrectly. That is all the regulation needed: the FDA does not need to add a layer of bureaucracy to the process of developing software.
This is terrible. I had no idea.
What fun is there in being in power, if you can’t control people’s lives for their own good.
The pleasure and pay for being an autocrat encourages thorough control, in minute detail, to promote the health and well being of the peasants. If it saves one life or $500 healthcare dollars, then it is worth it. No part of life is disconnected from health, well being, and expense to the State.
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C.S. Lewis: Of all tyrannies, a tyranny exercised for the good of its victims may be the most oppressive. It may be better to live under robber barons than under omnipotent moral busybodies.
The robber baron’s cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end, for they do so with the approval of their own conscience.
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In other areas, government departments are stepping in to Stop the Death from Quilts and Food
This is awful. The FDA could kill off an entire industry.
These bureaucrats are unbelievable.