The Wall Street Journal reported on December 2 Ascension Health has been sharing private patient data with the tech giant in an effort called Project Nightingale. The data involves patients from 21 states and was shared without their knowledge or specific permission.
Ascension is one of the largest health care systems in the country, with 2,600 hospitals, offices, and other facilities, the Journal reported. Google is not charging for the work yet, the report states.
The goal of the project is to develop “an intelligent suite of tools for clinicians, including a tool that aims to make health records more useful, more accessible and more searchable by pulling them into a single, easy-to-use interface for doctors,” stated David Feinberg, M.D., head of Google Health, in a blog post and video in response to public concerns.
Ethical, Legal Concerns
The criticisms of the deal are based on ethical and legal grounds. On November 18, the U.S. House of Representatives Energy and Commerce Committee demanded briefings from the companies on Project Nightingale.
“This initiative raises serious privacy concerns,” committee leaders stated in their letter to the companies. “[This] raises serious concerns whether Google can be a good steward of patients’ personal health information.”
The Citizens Council for Health Freedom calls the partnership “troubling” (see page 17).
Feinberg said the partnership is a “business associate agreement,” and although some Google staffers will have access to patients’ medical records, “these staff undergo HIPAA and medical ethics training, and are individually and explicitly approved by Ascension for a limited time.”
Google Cloud President Tariq Shaukat, on a video on the blog post, said the company’s goal is “ultimately improving outcomes, reducing costs, and saving lives.”
Although such research can be considered to be under blanket permission from patients, it is important for the business parties to have safeguards in place, says Roger Klein, M.D., J.D., who specializes in health care regulation and compliance and is a policy advisor to The Heartland Institute, which publishes Health Care News.
“It sounds like Google and Ascension could be considered to be doing research without specific consent—which may fall under a general research consent—which seems appropriate for a project of this magnitude,” said Klein. “I find it interesting that there has been no mention of institutional review board involvement.”
Although the partnership can be defended as valid research leading to general knowledge, the Google project does not appear to be purely scientific in intent, says Klein.
“While I think that [generalized knowledge] applies here, it is more in the nature of applied commercial-product research than pure medical investigation,” said Klein. “In a sense, it is reflective of newer modes of service provision enabled by ‘big data’ capabilities with which our regulatory efforts may not have kept pace.”