are clinical data that are not covered by H-W proprietary?
Yes, they could easily be. For example, try to use FOIA to see the full contents of an ancient NDA - you'll still get rejected because of the proprietary information it contains.
Here's a discussion of this (in the context of the secrecy surrounding clinical trial data):
While companies interact closely with the FDA through meetings and correspondence, neither the data that supports an NDA nor the full analysis and reasoning that supports an FDA regulatory decision is made public. In some cases, a subset of information about a drug may be obtained from the FDA by filing a request under the Freedom of Information Act (FOIA). However, submissions to the FDA are typically protected from public disclosure, even under FOIA, because FOIA allows the US government to withold publication of proprietary information such as trade secrets. Therefore, the vast majority of information about clinical trials — until quite recently, even the existence of a clinical trial — has remained a secret shared between the sponsoring company and the FDA.
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