DBR ON DATA

Security, Privacy and Information Governance

Author: Lee G. Petro (page 1 of 2)

US FDA Approaches to Artificial Intelligence

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Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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Enforcement Actions Launched by Securities and Exchange Commission – Heightened Scrutiny of Blockchain and Cryptocurrency Companies

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A recent flurry of activity by the Securities and Exchange Commission (SEC) in court, and strong talk on the Hill, gives a clear indication that the U.S. regulatory agency is making a significant push to rein in the current wild-west atmosphere of investments in Blockchain and cryptocurrency companies.

In the wake of the DAO Report issued by the SEC in July 2017, the agency released several Investor Alerts to warn the public of the risks associated with investing in initial coin offerings (ICOs), including an alert to warn investors to be careful about advertisements by celebrities promoting ICOs and other Blockchain-related investments. Moreover, the SEC chairman and his counterpart at the Commodity Futures Trading Commission (CFTC) have recently released statements and op-eds and appeared before the U.S. Senate Banking Committee to elevate the awareness of lawmakers and the public of some of these risks.

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Building the Blocks of Knowledge – NIST Releases Draft Blockchain Technology Overview

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On January 25, 2018, the National Institute of Standards and Technology (NIST) division of the U.S. Department of Commerce released a draft report of Blockchain technology (Overview). Recognizing the growing public awareness of the most well-known application of Blockchain technology – Bitcoin, the Overview draft report provides a high-level discussion of the technical components of Blockchain technology, addressing how data is encrypted, and how the data is verified and then distributed among the participating Blockchain parties. NIST is seeking comments on the scope and completeness of the draft Overview, which are due by February 23, 2018.

The Overview begins with a fairly detailed, yet accessible, overview of the architecture of Blockchain technology, covering both how data that is to be recorded and encrypted in the blocks, and how the individual blocks are then incorporated into the corresponding Blockchain. Discussions of hashing, nonces, forking and Merkle Trees are included, along with helpful charts for those with a preference for visuals.

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Pending IoT Legislation Would Impose Significant Obligations on Manufacturers

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With the House and Senate returning to Washington in September, two recently-introduced Senate bills seek to address perceived vulnerabilities in the security of Internet of Things (IoT) devices sold to the federal government and medical devices which regularly connect to the Internet.

Among the key takeaways in the legislation:

  • Legislation covers both products sold to the federal government and medical devices;
  • Legislation addresses “life of device” obligations of IoT device manufacturers;
  • Disclosure and Certification Requirements could create additional liability for manufacturers of Internet of Things devices.

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White House Issues ATC Report and Seeks Comments on IT Implementation Plan

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On August 30, the Trump administration unveiled an ambitious plan to upgrade the federal government’s cyberdefenses by shifting digital functions to the cloud and prioritizing security upgrades for the government’s most important systems.  In this plan, which in many ways continues the cyberefforts of the Obama administration, the White House’s American Technology Council (ATC) justified this large-scale approach due to what it characterized as the federal government’s longstanding less-than-adequate cyberefforts in the face of years of mounting digital threats.

The plan, grounded in the President’s May 2017 Executive Order (EO) 13,800,   tasked  the Director of the ATC to coordinate the preparation of a report to the President from the Secretary of the Department of Homeland Security (DHS), the Director of the Office of Management and Budget (OMB), and the Administrator of the General Services Administration (GSA), in consultation with the Secretary of Commerce (Commerce), regarding the modernization of Federal Information Technology (IT).  In accordance with EO 13,800, a draft IT Modernization report was submitted to the President last week.

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Time to Focus on Cybersecurity in Health Care

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In the wake of the WannaCry global attack that impacted the U.K.’s National Health Service, the need to protect valuable health care data has never been more urgent. The U.S. government has begun to take steps in the right direction with the passing of executive orders on cybersecurity, the Cybersecurity Act of 2015, and the Government Accountability Office report on the Internet of Things.

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