President Trump Will Welcome Palestinian President to White House, Meet with Australian Prime Minister in New York City

White HouseCongress Will Hold Hearings on Human Trafficking, Remittances and International Development, While Also Focusing on a Longer-Term Funding Measure for the Remainder of Fiscal Year 2017

President Donald Trump welcomed Argentine President Mauricio Macri to the White House last Thursday. In a joint statement, the two leaders committed to expanding bilateral trade and investments; strengthening cooperation to counter narco-trafficking, terrorist financing, money laundering, corruption and other illicit finance activities; and increasing cooperation on cyber policy. President Trump will welcome Palestinian President Mahmoud Abbas to the White House on Wednesday. The President will travel to New York City on Thursday for an event and will also meet with Australian Prime Minister Malcolm Turnbull.

President Trump signed multiple executive documents last week, including a Memorandum on aluminum and national security interests, as well as Executive Orders (E.O.) on veterans affairs, energy, agriculture, land management, and education. President Trump marked his 100th day in office with a Make America Great Again rally in Harrisburg, Pennsylvania, after signing two more E.O.s related to trade on Saturday.

On Friday, Secretary of Defense Jim Mattis honored two U.S. Army Rangers who died Thursday in Afghanistan. He said: “They carried out their operation against [the Islamic State of Iraq and Syria-Khorasan] in Afghanistan before making the ultimate sacrifice to defend our nation and our freedoms.”

Congress passed a short-term measure on Friday to fund the Federal Government for another week, allowing both chambers additional time to negotiate a longer-term measure that will fund the Government through the end of Fiscal Year 2017.  The Senate also approved the nomination of Sonny Perdue to serve as Secretary of the U.S. Department of Agriculture last Monday. Congress is in session this week.

North Korea – U.S. Continues Pressure on the International Community

Secretary of State Rex Tillerson chaired the U.N. Security Council on Friday, where he focused on North Korea’s illegal nuclear program and its continued provocative activities. He sought to get the Council to act and leverage additional pressure on North Korea, saying:

“For too long, the international community has been reactive in addressing North Korea. Those days must come to an end.”

He outlined steps that the international community could undertake to leverage North Korea into abandoning its nuclear program. The White House released a brief statement on Friday afternoon acknowledging President Trump was briefed on North Korea’s failed missile test that day.

On Wednesday, after a briefing to the Senators at the White House, Secretary Tillerson, Defense Secretary Mattis, and Director of National Intelligence Dan Coats issued a joint statement on North Korea’s unlawful weapons programs and nuclear and ballistic missile tests, saying each provocation jeopardizes stability in Northeast Asia and poses a growing threat to U.S. allies and the U.S. homeland. The officials noted: “We are engaging responsible members of the international community to increase pressure on the D.P.R.K. in order to convince the regime to de-escalate and return to the path of dialogue. We will maintain our close coordination and cooperation with our Allies, especially the Republic of Korea and Japan, as we work together to preserve stability and prosperity in the region. The United States seeks stability and the peaceful denuclearization of the Korean peninsula. We remain open to negotiations towards that goal. However, we remain prepared to defend ourselves and our Allies.”

Chairman of the Joint Chiefs of Staff Joseph Dunford also participated in the Senate briefing.  In a summary, the Defense Department recapped North Korea as an urgent national security threat and a top foreign policy priority for the U.S. Government.

On 27 April, the head of U.S. Pacific Command recommended that the U.S. military develop capabilities that can directly defend against North Korean artillery. Testifying at a Senate Armed Services Committee hearing last week, Adm. Harry Harris shared that the U.S. currently cannot counter an artillery barrage from North Korea. He explained the missile defense system that the United States is deploying to South Korea, is only designed to intercept ballistic missiles. North Korea currently possesses roughly 4,000 artillery pieces positioned near the demilitarized zone. Committee Chairman John McCain (R-Arizona) noted that these pieces had the potential to target the South Korean capital, Seoul, and its metropolitan area of 26 million people.

South Korea – McMaster Affirms Missile Defense

On 30 April, National Security Adviser Lt. Gen. H.R. McMaster confirmed that the United States would adhere to its agreement with South Korea for a new missile defense system, but indicated that payment for the system might be renegotiated. The Terminal High Altitude Area Defense system, also known as THAAD, is being rolled out in response to military provocations from North Korea.

In an interview with “Fox News Sunday,” McMaster shared that he told his South Korean counterpart that “until any renegotiation, that the deal’s in place,” but explained that, “what the president’s asked us to do is to look across all of our alliances and to have appropriate burden-sharing, responsibility-sharing.” President Donald Trump said in a recent interview that he “informed South Korea it would be appropriate if they paid” for the missile defense system.

Syria, Iraq – Combating ISIS

The Pentagon gave an update last Friday on the U.S. and Coalition military forces’ efforts to combat the Islamic State of Iraq and Syria (ISIS). Coalition forces conducted 24 strikes consisting of 30 engagements against ISIS targets in Syria. In Iraq, Coalition forces conducted eight strikes consisting of 24 engagements against ISIS targets, coordinated with and in support of the Iraqi government. The destruction of ISIS targets in both countries also further limits the group’s ability to project terror and conduct external operations throughout the region and the rest of the world, according to task force officials.

U.S. Ambassador to the United Nations Nikki Haley said on Thursday at a U.N. Security Council session she chaired on the humanitarian crisis in Syria:

“All eyes and all pressure now need to go to Russia because they are the ones that could stop this if they wanted to…the images don’t lie. The humanitarian workers don’t lie. The fact that they can’t get the assistance they need – that’s not lying. What is, is to continue to give Russia a pass for allowing this terrible situation to occur. I will continue to press the Security Council to act, to do something, regardless of if the Russians continue to veto it, because it is our voice that needs to be heard.”

The Department of State designated Mubarak Mohammed A Alotaibi as a Specially Designated Global Terrorist (SDGT) under Executive Order E.O. 13224 on 27 April.  Alotaibi is the Syria-based deputy leader of Islamic State of Iraq and Syria’s (ISIS) affiliate in Saudi Arabia, which was designated by the U.S. Department of State as a SDGT under E.O. 13224 on 19 May 2016.

On 24 April, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced new sanctions targeting 271 Syrian individuals in response to the 4 April sarin gas attack in Syria. According to an accompanying press release, the action – one of the largest OFAC has ever taken – targets employees of Syria’s Scientific Studies and Research Center (SSRC). They have been added to OFAC’s list of Specially Designated Nationals (also known as the SDN List) pursuant to Executive Order 13582, “Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria.” The full list of newly-designated individuals can be found here.

Afghanistan – Review of U.S. Policy

Defense Secretary Mattis added another stop to his Middle East trip last week that focused on a theme of combatting ISIS. The Secretary was in Kabul, Afghanistan, last Monday. At a press conference Secretary Mattis said of the 21 April Taliban attack on an Afghan military base and mosque that killed more than 100 people: “As if we needed a reminder of the type of enemy we’re up against, the killing of Afghan citizens and soldiers — protectors of the people — just as they were coming out of a mosque, a house of worship, it certainly characterizes this fight for exactly what it is. These people have no religious foundation. They are not devout anything, and it shows why we stand with the people of this country against such heinous acts perpetrated by this barbaric enemy and what they do.”

Regarding President Trump’s directive to review of U.S. policy in Afghanistan, Secretary Mattis said: “This dictates an ongoing dialogue with Afghanistan’s leadership, and that’s why I came here: to get with President Ghani and his ministers and hear directly and at length from … General Nicholson to provide my best assessment and advice as we go forward.”

NAFTA – U.S. Withdrawal Averted

President Trump considered signing an order last week that would have withdrawn the United States from the North American Free Trade Agreement (NAFTA). After news of the possible action emerged, the leaders of Mexico and Canada, interested stakeholders, and Members of Congress rallied to call the White House and urge against such action. President Trump said in an interview on Thursday: “I was all set to terminate [NAFTA]. I looked forward to terminating. I was going to do it.” Later in the interview, the President added he reserves the right to change his mind – “I can always terminate.”

Nominations – Update

The Senate has yet to schedule a final vote on Amb. Robert Lighthizer’s nomination to serve as U.S. Trade Representative.  A vote is expected to happen in the next couple of weeks.

Last week, President Trump announced his intent to nominate the following individuals: (1) Kari A. Bingen to serve as Principal Deputy Under Secretary of Defense for Intelligence.  Ms. Bingen currently serves as the policy director for the House Armed Services Committee. (2) Robert Story Karem to serve as Assistant Secretary of Defense for International Security Affairs.  Mr. Karem most recently served on the Presidential Transition Team as an advisor to Central Intelligence Agency Director, Mike Pompeo, during his confirmation process.  He previously served in the White House as a Middle East policy advisor to former Vice President Richard B. Cheney.

Congressional Hearings This Week

  • On Tuesday, 2 May, the House Foreign Affairs Subcommittee on Global Human Rights is scheduled to hold a hearing titled “Wining the Fight Against Human Trafficking: The Frederick Douglass Reauthorization Act.”

  • On Tuesday, 2 May, the Senate Banking, Housing, and Urban Affairs Committee is scheduled to hold a hearing titled “Examining the U.S. – E.U. Covered Agreements.”

  • On Tuesday, 2 May, the Senate Foreign Relations Committee has scheduled a hearing to consider the nomination of the Honorable Terry Brandstad, to serve as U.S. Ambassador to China.

  • On Wednesday, 3 May, the House Foreign Affairs Committee is scheduled to hold a hearing to consider the following bills:

    • R. 1625 – To amend the State Department Basic Authorities Act of 1956 to include severe forms of trafficking in persons within the definition of transnational organized crime for purposes of the rewards program of the Department of State, and for other purposes.

    • R. 1677 – To halt the wholesale slaughter of the Syrian people, encourage a negotiated political settlement, and hold Syrian human rights abusers accountable for their crimes.

    • R. 2200 – To reauthorize the Trafficking Victims Protection Act of 2000, and for other purposes.

  • On Wednesday, 3 May, the Senate Foreign Relations Subcommittee on International Economic, Energy, and Environmental Policy is scheduled to hold a hearing titled “Global Philanthropy and Remittances and International Development.”

  • On Thursday, 4 May, the Senate Foreign Relations Committee is scheduled to hold a hearing titled “International Development: Value Added Through Private Sector Engagement.”

Looking Ahead

Washington is expected to focus on the following upcoming events:

  • 3 May: President Trump will welcome Palestinian President Mahmoud Abbas

  • 4 May: President Trump travels to New York City, where he will hold a bilateral meeting with Australian Prime Minister Malcolm Turnbull

  • May: Formal notification to Congress of intent to renegotiate NAFTA expected

  • 25 May: President Trump to attend the NATO Leaders Meeting in Belgium

  • 26-28 May: President Trump to attend the G-7 Leaders’ Summit in Taormina, Sicily

  • 18-20 June: SelectUSA Investment Summit in National Harbor, Maryland

ARTICLE BY Stacy A. Swanson and Pooja Virkar of Squire Patton Boggs (US) LLP

© Copyright 2017 Squire Patton Boggs (US) LLP

The White House’s Revisions to its Breach Response Policy For Federal Agencies and Departments Also Affect Contractors

White House data breach responseOn January 3, 2017, the Obama Administration issued a memorandum to all executive departments and agencies setting for a comprehensive policy for handling breaches of personally identifiable information (the “Memorandum”), replacing earlier guidance. Importantly, the Memorandum also affects federal agency contractors as well as grant recipients.

The Memorandum is not the first set of guidance to federal agencies and departments for reporting breaches of personally identifiable information (PII), but it establishes minimum standards going forward (agencies have to comply within 180 days from the date of the Memorandum). The Memorandum makes clear that it is not setting policy on information security, or protecting against malicious cyber activities and similar activities; topics related to the recent fiery debates concerning the 2016 election results and Russian influence.

The Memorandum sets out a detailed breach response policy covering topics such as preparedness, establishing a response plan, assessing incident risk, mitigation, and notification. For organizations that have not created a comprehensive breach response plan, the Memorandum could be a helpful resource, even for those not subject to it. But it should not be the only resource.

Below are some observations and distinctions worth noting.

  • PII definition. Unlike most state breach notification laws, the Memorandum defines PII broadly: information that can be used to distinguish to trace an individual’s identity, either alone or when combined with other information that is linked or linkable to a specific individual. So, for example, the notification obligation for a federal contractor will not just apply if Social Security numbers or credit card numbers have been compromised.
  • Breach definition. Breaches are not limited phishing attacks, hackings or similar intrusions. They include lost physical documents, sending an email to the wrong person, or inadvertently posting PII on a public website.
  • Training. Breach response training must be provided to individuals before they have access to federal PII. That training should advise the individuals not to wait for confirmation of a breach before reporting to the agency. A belief (or hope) that one will find that lost mobile device should not delay reporting.
  • Required provisions in federal contracts. Federal contractors that collect or maintain federal PII or use or operate an information system for a federal agency must be subject to certain requirements by contract. The Memorandum requires agencies to update their contracts with contractors to ensure the contracts contain certain provisions, such as requiring contractors to (i) encrypt PII in accordance with OMB Circular A-130, (ii) train employees, (iii) report suspected or confirmed breaches; (iv) be able to determine what PII was or could have been accessed and by whom, and identify initial attack vectors, and (v) allow for inspection and forensic analysis. Because agencies must ensure these provisions are uniform and consistent in all contracts, negotiation will be difficult. The Federal Acquisition Regulatory Council is directed to work the Office of Management and Budget to promptly develop appropriate contract clauses and regulatory coverage to address these requirements.
  • Risk of harm analysis. Agencies will need to go through a complex risk of harm analysis to determine the appropriate breach response. Notably, encryption of PII is not an automatic exception to notification.
  • Notification. The rules for timing and content of breach notification are similar to those in many of the state breach notification laws. The Memorandum also advises agencies to anticipate undeliverable mail and to have procedures for secondary notification, something not clearly expressed in most state notification laws. The Memorandum also suggests website FAQs, which can be more easily updated and tailored. Agency heads have ultimate responsibility for deciding whether notify. They can consider over-notification and should try to provide a single notice to cover multiple notification requirements. They also can require contractors to provide notification following contractor breaches.
  • Tabletop Exercises. The Memorandum makes clear that testing breach response plans is essential and expressly requires that tabletop exercises be conducted at least annually.

Federal contractors and federal grant recipients that have access to federal PII will need to revisit (or develop) their own breach response plans to ensure they comply with the Memorandum, as well as the requirements of the applicable federal agency or department which can be more stringent. Of course, those plans must also incorporate other breach response obligations the organizations may have, whether those obligations flow from other federal laws (e.g., HIPAA), state laws, or contracts with other entities. Putting aside presidential politics, cybersecurity threats are growing and increased regulation, enforcement and litigation exposure is likely.

Jackson Lewis P.C. © 2017

White House Announces Long-Awaited Trans-Pacific Partnership Agreement

The Obama administration released the full text of the Trans-Pacific Partnership (TPP) agreement, on November 5, kicking off a 90-day window for congressional review.

The TPP would arguably be the largest free trade agreement in history when considering the economies of the 12 Pacific Rim member countries, covering approximately 40% of the global economy. The agreement must now be individually approved by each of the 12 countries: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam.

If ratified, the TPP will be one of President Obama’s crowning achievements. Obama has championed the landmark agreement as a vehicle for opening new markets to American products and establishing higher labor and environmental standards, while building an economic bloc in the Asia-Pacific region to compete with China. (See the White House Fact Sheet here.)

Obama now has an uphill climb as he launches a major public relations campaign to sell the agreement to the American public. The debate will be contentious, with a bitterly divided Congress voting on the final agreement in early 2016 – well into the election year as presidential primary elections are taking place.

Under pressure from labor unions to oppose the deal, Democrats have largely withheld support. In early October, former Secretary of State, and current presidential candidate, Hillary Clinton came out against the deal which she once called the “gold standard” of trade agreements. Last spring, Obama relied on Republicans in Congress to pass the underlying fast-track trade authority bill, with only 28 Democrats in the House voting in favor of passage. Under fast-track authority, Congress can approve or reject the agreement, but not amend it.

Note: The Office of the United States Trade Representative (USTR) posted the agreement in roughly two hundred separate PDF documents. The Washington Post promptly published a search function on their website for easier searching.

© 2015 Foley & Lardner LLP

White House Releases ‘Modernizing & Streamlining Our Legal Immigration System for the 21st Century’

The White House has just released a new report titled “Modernizing & Streamlining our Legal Immigration System for the 21st Century,” which builds on the President’s executive actions of Nov. 21, 2014. This report provides for plans to improve the immigration system to modernize and streamline the processes for certain visa categories and to address security issues. The report also calls for plans to strengthen the United States’ humanitarian system by providing benefits for certain individuals.

The report specifically addresses the EB-5 program in important ways. The White House acknowledges that the U.S. Immigration and Citizenship Services (USCIS) has undergone significant changes in an effort to enhance the program’s processes and to improve its integrity, including the creation of a new team with expertise in economic analysis and specific EB-5 components, as well as the issuance of updated policy guidance to provide better clarity as to program requirements.

The White House recognizes that there is a need for additional enhancements and improvements to address the integrity and impact of the EB-5 program. Specifically, the White House recommends additional measures including enhancements to avoid fraud, abuse, and criminal activity; measures to ensure that the program is reaching its full potential in terms of job creation and economic growth; and recommendations to streamline the program to make it efficient and stable for participants in the program, including petitioners and Regional Centers.

The report announces that Homeland Security Secretary Jeh Johnson has adopted the creation of a new protocol, announced previously, intended to insulate the EB-5 program from “the reality or perception of improper outside influence.” Further, the report reiterates the Secretary’s recommendations to Congress to provide the department with authority to deny or revoke cases based upon serious misconduct; prohibit individuals with past criminal or securities-related violations from program participation, and a mechanism to ensure regional center compliance with securities laws. It is notable that these recommendations are included in the bill that Senator Leahy and Senator Grassley introduced on June 3, 2015.

The report makes two specific recommendations. First, it announces that DHS will pursue rulemaking to improve program integrity, including conflict-of-interest disclosures by Regional Center principals, enhanced background checks and public disclosure requirements, and an increase in the minimum qualifying level of investment. The department will also pursue new regulations to improve adjudication of Regional Center applications. Second, the report announces that the State Department will amend guidance in the Foreign Affairs Manual to permit potential EB-5 investors to obtain visitor visas for the purpose of evaluating investment.

In addition, DHS will propose a parole program for entrepreneurs who “provide a significant public benefit.” The examples of “significant public benefit” include innovation and job creation through new technology development.

©2015 Greenberg Traurig, LLP. All rights reserved.

White House Releases ‘Modernizing & Streamlining Our Legal Immigration System for the 21st Century’

The White House has just released a new report titled “Modernizing & Streamlining our Legal Immigration System for the 21st Century,” which builds on the President’s executive actions of Nov. 21, 2014. This report provides for plans to improve the immigration system to modernize and streamline the processes for certain visa categories and to address security issues. The report also calls for plans to strengthen the United States’ humanitarian system by providing benefits for certain individuals.

The report specifically addresses the EB-5 program in important ways. The White House acknowledges that the U.S. Immigration and Citizenship Services (USCIS) has undergone significant changes in an effort to enhance the program’s processes and to improve its integrity, including the creation of a new team with expertise in economic analysis and specific EB-5 components, as well as the issuance of updated policy guidance to provide better clarity as to program requirements.

The White House recognizes that there is a need for additional enhancements and improvements to address the integrity and impact of the EB-5 program. Specifically, the White House recommends additional measures including enhancements to avoid fraud, abuse, and criminal activity; measures to ensure that the program is reaching its full potential in terms of job creation and economic growth; and recommendations to streamline the program to make it efficient and stable for participants in the program, including petitioners and Regional Centers.

The report announces that Homeland Security Secretary Jeh Johnson has adopted the creation of a new protocol, announced previously, intended to insulate the EB-5 program from “the reality or perception of improper outside influence.” Further, the report reiterates the Secretary’s recommendations to Congress to provide the department with authority to deny or revoke cases based upon serious misconduct; prohibit individuals with past criminal or securities-related violations from program participation, and a mechanism to ensure regional center compliance with securities laws. It is notable that these recommendations are included in the bill that Senator Leahy and Senator Grassley introduced on June 3, 2015.

The report makes two specific recommendations. First, it announces that DHS will pursue rulemaking to improve program integrity, including conflict-of-interest disclosures by Regional Center principals, enhanced background checks and public disclosure requirements, and an increase in the minimum qualifying level of investment. The department will also pursue new regulations to improve adjudication of Regional Center applications. Second, the report announces that the State Department will amend guidance in the Foreign Affairs Manual to permit potential EB-5 investors to obtain visitor visas for the purpose of evaluating investment.

In addition, DHS will propose a parole program for entrepreneurs who “provide a significant public benefit.” The examples of “significant public benefit” include innovation and job creation through new technology development.

©2015 Greenberg Traurig, LLP. All rights reserved.

White House Will Unveil Cyber Executive Actions At A Summit This Week

Squire Patton Boggs (US) LLP law firm

Legislative Activity

This Week’s Hearings:

  • Wednesday, February 11: The Senate Commerce, Science and Transportation Committee will hold a hearing titled “The Connected World: Examining the Internet of Things.”

  • Thursday, February 12: The House Homeland Security Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies will host a hearing titled “Emerging Threats and Technologies to Protect the Homeland.”

  • Thursday, February 12: The House Education and the Workforce Subcommittee on Early Childhood, Elementary and Secondary Education will hold a hearing titled “How Emerging Technology Affects Student Privacy.”

  • Thursday, February 12: The House Science, Space and Technology Subcommittee on Research and Technology and Subcommittee on Oversight will hold a joint hearing titled “Can Americans Trust the Privacy and Security of their Information on HealthCare.gov?”

Regulatory Activity

White House Will Unveil Cyber Executive Actions at a Summit this Week

On Friday, February 13, the White House will hold its Summit on Cybersecurity and Consumer Protection at Stanford University. President Obama will be speaking at the Summit and plans to issue a new Executive Order focusing on ways to increase cybersecurity information sharing between the private sector and the U.S. Department of Homeland Security (DHS).

The executive action will likely expand the current work that DHS’s National Cybersecurity and Communications Integration Center (NCCIC) does to include a new concept of Information Sharing and Analysis Organizations (ISAO), which was briefly previewed by the President last month. As currently discussed, ISAOs would be designed to share information across multiple industry sectors to supplement the work of the current network of Information Sharing and Analysis Centers (ISACs).  According to press reports from government officials, the executive action is expected to create a network of ISAOs that would be managed by DHS in the beginning and eventually would become a privately-run entity. Several government officials and industry representatives have said that the President’s action will represent a step forward to improving the current information sharing platforms but they also recognize that information sharing legislation is still needed.

In addition to the Summit on Friday, the National Institute of Standards and Technology (NIST) will hold a half-day workshop on Thursday focused on the technical aspects of consumer security. The Office of Science and Technology Policy will also host a meeting leading up to the Summit on Thursday focused on cybersecurity workforce development.

White House Blog Highlights Future Action on Cyber Risk Management

Last week, White House Cybersecurity Coordinator Michael Daniel wrote a blog post on how companies can strengthen their cyber risk management and the role of the federal government in incentivizing stronger cybersecurity practices in the private sector. He notes in the post that the White House believes “the market offers the most effective incentives for the private sector to adopt strong cybersecurity practices,” but also stated that the Obama Administration will continue to work in a variety of areas to support these efforts by streamlining regulations, investing in cybersecurity research and development, and updating federal procurement policies and practice. Daniel wrote that the White House is working with federal agencies and critical infrastructure to identify regulations that are excessively burdensome, conflicting, or ineffective and will release a report on the findings no later than February 2016. Additionally, the White House plans to release a report this spring on the key priorities for cybersecurity research and development over the next three to five years.

The blog post also noted that the White House will not pursue public recognition as a means of incentivizing the private sector to adopt cybersecurity best practices or the NIST Cybersecurity Framework given that this could take away from the voluntary nature of the Framework. While Daniel did not mention liability protection as an incentive for greater information sharing in the blog post, it is still a possible incentive that the White House would support given that it was also included in the information sharing legislative proposal that the President released last month.

ARTICLE BY

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The White House Big Data Report & Apple’s iOS 8: Shining the Light on an Alternative Approach to Privacy and Biomedical Research

DrinkerBiddle

Big data derives from “the growing technological ability to capture, aggregate, and process an ever-greater volume, velocity, and variety of data.”[i] Apple’s just-releasediOS 8 software development kit (“iOS 8 SDK”) highlights this growth.[ii] The iOS 8 SDK touts over 4,000 application programming interface calls including “greater extensibility” and “new frameworks.”iii For example, HomeKit and HealthKit, two of these new frameworks, serve as hubs for data generated by other applications and provide user interfaces to manage that data and related functionality.[iv] HealthKit’s APIs “provide the ability for health and fitness apps to communicate with each other … to provide a more comprehensive way to manage your health and fitness.”[v] HomeKit integrates home automation functions in a central location within the iOS device, allowing users to lock/unlock doors, turn on/off cameras, change or view thermostat settings, turn lights on/off, open garage doors and more – all from a single app.[vi] The iOS 8 SDK will inevitably lead to the development of countless apps and other technologies that “capture, aggregate, and process an ever-greater volume, velocity, and variety of data,” contributing immense volumes of data to the already-gargantuan big data ecosystem.

In the context of our health and wellbeing, big data – which includes, but is definitely not limited to, data generated by future iOS 8-related technologies – has boundless potential and can have a momentous impact on biomedical research, leading to new therapies and improved health outcomes. The big data reports recently issued by the White House and the President’s Council of Advisors on Science and Technology (“PCAST”) echo this fact. However, these reports also emphasize the challenges posed by applying the current approach to privacy to big data, including the focus on notice and consent.

After providing some background, this article examines the impact of big data on medical research. It then explores the privacy challenges posed by focusing on notice and consent with respect to big data. Finally, this article describes an alternative approach to privacy suggested by the big data reports and its application to biomedical research.

Background

On May 1, 2014, the White House released its report on big data, “Big Data: Seizing Opportunities, Preserving Values” (“WH Report”). The WH Report was supported by a separate effort and report produced by PCAST, “Big Data and Privacy: A Technological Perspective” (“PCAST Report”).[vii] The privacy implications of the eports on biomedical research – an area where big data can arguably have the greatest impact – are significant.

Notice and consent provide the foundation upon which privacy laws are built. Accordingly, it can be difficult to envision a situation where these conceptual underpinnings, while still important, begin to yield to a new approach. However, that is exactly what the reports suggest in the context of big data. As HealthKit and iOS 8 SDK demonstrate, we live in a world where health data is generated in numerous ways, both inside and outside of the traditional patient-doctor relationship. If given access to all this data, researchers can better analyze the effectiveness of existing therapies, develop new therapies faster, and more accurately predict and suggest measures to avoid the onset of disease, all leading to improved health outcomes. However, existing privacy laws often restrict researchers’ access to such data without first soliciting and obtaining proof of appropriate notice and consent.[viii] Focusing on individual notice and consent in some instances can be unnecessarily restrictive and can stall the discovery and development of new therapies. This is exacerbated by the fact that de-identification (or pseudonymization) – a process typically relied upon to alleviate some of these obstacles – is losing its effectiveness or would require stripping data of much meaningful value. Recognizing these flaws, the WH Report suggests a new approach where the focus is taken off of the collection of data and turned to the ways in which parties, including biomedical researchers, use data – an approach that allows researchers to maximize the possibilities of big data, while protecting individual privacy and ensuring that data is processed in a reasonable way.

The Benefits of Big Data to Biomedical Research

Before discussing why a new approach to privacy in the context of big data and biomedical research may be necessary, it is first important to understand the role of big data in research. As noted, the concept of big data encompasses “the growing technological ability to capture, aggregate, and process an ever-greater volume, velocity, and variety of data.”[ix] The word “growing” is essential here, as the sources of data contributing to the big data ecosystem are extensive and will continue to expand, especially as Internet-enabled devices such as those contemplated by HomeKit continue to develop.[x] These sources include not only the traditional doctor-patient relationship, but also consumer-generated and other non-traditional sources of health data such as those contemplated by HealthKit, including wearable technologies (e.g., Fitbit), patient-support sites (e.g., PatientsLikeMe.com), wellness programs, electronic/personal health records, etc. These sources expand even further when non-health data is combined with lifestyle and financial data.[xi]

The WH Report recognizes that these new abilities to collect and process information have the potential to bring about “unexpected … advancements in our quality of life.”[xii] The ability of researchers to analyze this vast amount of data can help “identify clinical treatments, prescription drugs, and public health interventions that may not appear to be effective in smaller samples, across broad populations, or using traditional research methods.”[xiii] In some instances, big data can in fact be the necessary component of a life-changing discovery.[xiv]

Further, the WH Report finds that big data holds the key to fully realizing the promise of predictive medicine, whereby doctors and researchers can fully analyze an individual’s health status and genetic information to better predict the onset of disease and/or how an individual might respond to specific therapies.[xv] These findings have the ability to affect not only particular patients but also family members and others with a similar genetic makeup.[xvi] It is worth noting that the WH Report highlights bio-banks and their role in “confronting important questions about personal privacy in the context of health research and treatment.”[xvii]

In summary, big data has a profound impact on biomedical research and, as a necessary result, on those that benefit from the fruits of researchers’ labor. The key to its realization is a privacy regime that can unlock for researchers vast amounts of different types of data obtained from diverse sources.

Problems With the Current Approach

Where the use of information is not directly regulated by the existing privacy framework, providing consumers with notice and choice regarding the processing of their personal information has become the de facto rule. Where the collection and use of information is specifically regulated (e.g., HIPAA, FCRA, etc.), notice and consent is required whenever information is used or shared in a way not permitted under the relevant statute. For example, under HIPAA, a doctor can disclose a patient’s personal health information for treatment purposes (permissible use) but would need to provide the patient with notice and obtain consent before disclosing the same information for marketing purposes (impermissible use). To avoid this obligation, entities seeking to share data in a way not described in the privacy notice and/or permitted under applicable law can de-identify the data, to purportedly make the data anonymous (for example, John Smith drives a white Honda and makes $55,000/year (identified) v. Person X drives a white Honda and makes $55,000/year (de-identified)).[xviii] Except under very limited circumstances (e.g., HIPAA limited data sets), the requirements regarding notice and consent apply equally to biomedical research as to more commercial uses.

In the context of big data, the first problem with notice and consent is that it places an enormous burden on the individual to manage all of the relevant privacy notices applicable to the processing of that individual’s data. In other words, it requires individuals to analyze each and every privacy notice applicable to them (which could be hundreds, if not more), determine whether those data collectors share information and with whom, and then attempt to track that information down as necessary. As the PCAST Report not-so-delicately states, “[i]n some fantasy world, users actually read these notices, understand their legal implications (consulting their attorneys if necessary), negotiate with other providers of similar services to get better privacy treatment, and only then click to indicate their consent. Reality is different.”[xix] This is aggravated by the fact that relevant privacy terms are often buried in privacy notices using legalese and provided on a take-it-or-leave-it basis.[xx] Although notice and consent may still play an important role where there is a direct connection between data collectors and individuals, it is evident why such a model loses its meaning when information is collected from a number of varied sources and those analyzing the data have no direct relationship with individuals.

Second, even where specific privacy regulations apply to the collection and use of personal information, such rules rarely consider or routinely allow for the disclosure of that information to researchers for biomedical research purposes, thus requiring researchers to independently provide notice and obtain consent. As the WH Report points out, “[t]he privacy frameworks that currently cover information now used in health may not be well suited to … facilitate the research that drives them.”[xxi] And as previously noted, often times biomedical researchers require non-health information, including lifestyle and financial data, if they want to maximize the benefits of big data. “These types of data are subjected to different and sometimes conflicting federal and state regulation,” if any regulation at all.[xxii]

Lastly, the ability to overcome de-identification is becoming easier due to “effective techniques … to pull the pieces back together through ‘re-identification’.”[xxiii] In fact, the very techniques used to analyze big data for legitimate purposes are the same advanced algorithms and technologies that allow re-identification of otherwise anonymous data.[xxiv] Moreover, “meaningful de-identification may strip the data of both its usefulness and the ability to ensure its provenance and accountability.”[xxv] In other words, de-identification is not as useful as it once was and further stripping data in an effort to overcome this fact could well extinguish any value the data may have (using the example above, car type and salary may still provide marketers with meaningful information (e.g., individuals with a similar salary may be interested in that car type), but the information “white Honda” alone is worthless). [xxvi]

The consequences of all this are either 1) biomedical researchers are deprived of valuable data or provided meaningless de-identified data, or 2) individuals have no idea that their information is being processed for research purposes. Both the benefits and obstacles relating to big data and biomedical research led to the WH Report’s recognition that we may need “to look closely at the notice and consent framework” because “focusing on controlling the collection and retention of personal data, while important, may no longer be sufficient to protect personal privacy.”xxvii] Further, as the PCAST Report points out, and as reflected in the WH Report, “notice and consent is defeated by exactly the positive benefits that big data enables: new, non-obvious, unexpectedly powerful uses of data.”xxviii So what does this new approach look like?

Alternative Approach to Big Data: Focus on Use, Not Collection[xxix]

The WH Report does not provide specific proposals. Rather, it suggests a framework for a new approach to big data that focuses on the type of use of such data and associated security controls, as opposed to whether notice was provided and consent obtained at the point of its collection. Re-focusing attention to the context and ways big data is used (including the ways in which results generated from big data analysis are used) could have many advantages for individuals and biomedical researchers. For example, as noted above, the notice and consent model places the burden on the individual to manage all of the relevant privacy notices applicable to the processing of that individual’s data and provides no backstop when those efforts fail or no attempt to manage notice provisions is made. Where the attention focuses on the context and uses of data, it shifts the burden of managing privacy expectations to the data collector and it holds entities that utilize big data (e.g., researchers) accountable for how data is used and any negative consequences it yields.[xxx]

The following are some specific considerations drawn from the reports regarding how a potential use framework might work:

  • Provide that all information used by researchers, regardless of the source, is subject to reasonable privacy protections similar to those prescribed under HIPAA.[xxxi] For example, any data relied upon by researchers can only be used and shared for biomedical research purposes.
  • Create special authorities or bodies to determine reasonable uses for big data utilized by researchers so as to realize the potential of big data while preserving individual privacy expectations.[xxxii] This would include recognizing and controlling harmful uses of data, including any actions that would lead to an adverse consequence to an individual.[xxxiii]
  • Develop a central research database for big data accessible to all biomedical researchers, with universal standards and architecture to facilitate controlled access to the data contained therein.[xxxiv]
  • Provide individuals with notice and choice whenever big data is used to make a decision regarding a particular individual.[xxxv]
  • Where individuals may not want certain data to enter the big data ecosystem, allow them to create standardized data use profiles that must be honored by data collectors. Such profiles could prohibit the data collector from sharing any information associated with such individuals or their devices.
  • Require reasonable security measures to protect data and any findings derived from big data, including encryption requirements.[xxxvi] 
  • Regulate inappropriate uses or disclosures of research information, and make parties liable for any adverse consequences of privacy violations.[xxxvii]

By offering these suggestions for public debate, the WH and PCAST reports have only initiated the discussion of a new approach to privacy, big data and biomedical research. Plainly, these proposals bring with them numerous questions and issues that must be answered and resolved before any transition can be contemplated (notably, what are appropriate uses and who determines this?).

Conclusion

Technologies utilizing the iOS 8 SDK, including HealthKit and HomeKit, illustrate the technological growth contributing to the big data environment. The WH and PCAST reports exemplify the endless possibilities that can be derived from this environment, as well as some of the important privacy issues affecting our ability to harness these possibilities. The reports constitute their authors’ consensus view that the existing approach to big data and biomedical research restricts the true potential big data can have on research, while providing individuals with little-to-no meaningful privacy protections. Whether the suggestions contained in the WH and PCAST reports will be – or should be – further developed is an open question that will undoubtedly lead to a healthy debate. Yet, in the case of the PCAST Report, the sheer diversity of players recognizing big data’s potential and associated privacy implications – including, but not limited to, leading representatives and academics from the Broad Institute of Harvard and MIT, UC-Berkeley, Microsoft, Google, National Academy of Engineering, University of Texas at Austin, University of Michigan, Princeton University, Zetta Venture Partners, National Quality Forum and others – provides hope that this potential will one day be realized – in a way that appropriately protects our privacy.[xxxviii]

WH Report Summary: click here.

PCAST Report Summary: click here.

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[i] WH Report, p. 2.

[ii] See Apple’s June 2, 2014, press release, Apple Releases iOS 8 SDK With Over 4,000 New APIs, last found at http://www.apple.com/pr/library/2014/06/02Apple-Releases-iOS-8-SDK-With-Over-4-000-New-APIs.html.

[iii] Id.

[iv] Id.

[v] Id.

[vi] Id.

[vii] The White House and PCAST issued summaries of their respective reports, including their policy recommendations, which can be easily found at the links following this article.

[viii] WH Report, p. 7.

[ix] WH Report, p. 2.

[x] WH Report, p. 5.

[xi] WH Report, p. 23.

[xii] WH Report, p. 3.

[xiii] WH Report, p. 23.

[xiv] WH Report, p. 6 (the WH Report includes two research-related examples of the impact of big data on research, including a study whereby the large number of data sets made “the critical difference in identifying the meaningful genetic variant for a disease.”).

[xv] WH Report, p. 23.

[xvi] WH Report, p. 23.

[xvii] WH Report, p. 23.

[xviii] In privacy law, “anonymous” data is often considered a subset of “de-identified” data. “Anonymized” data means the data has been de-identified and is incapable of being re-identified by anyone. “Pseudonymized” data, the other primary subset of “de-identified” data, replaces identifying data elements with a pseudonym (e.g., random id number), but can be re-identified by anyone holding the key. If the key was destroyed, “pseudonymized” data would become “anonymized” data.

[xix] PCAST Report, p. 38.

[xx] PCAST Report, p. 38.

[xxi] WH Report, p. 23.

[xxii] WH Report, p. 23.

[xxiii] WH Report, p. 8.

[xxiv] WH Report, p. 54; PCAST Report, pp. 38-39.

[xxv] WH Report, p. 8.

[xxvi] The PCAST Report does recognize that de-identification can be “useful as an added safeguard.” SePCAST Report, p. 39. Further, other leading regulators and academics consider de-identification a key part of protecting privacy, as it “drastically reduces the risk that personal information will be used or disclosed for unauthorized or malicious purposes.“ Dispelling the Myths Surrounding De-identification: Anonymization Remains a Strong Tool for Protecting Privacy, Ann Cavoukian, Ph.D. and Khaled El Emam, Ph.D. (2011), last found at http://www.ipc.on.ca/images/Resources/anonymization.pdf. Drs. Cavourkian and El Emam argue that “[w]hile it is clearly not foolproof, it remains a valuable and important mechanism in protecting personal data, and must not be abandoned.” Id.

[xxvii] WH Report, p. 54.

[xxviii] PCAST Report, p. 38; WH Report, p. 54.

[xxix] This approach is not one of the official policy recommendations contained in the WH Report. However, as discussed above, the WH Report discusses the impact of big data on biomedical research, as well as this new approach, extensively. Further, to the extent order has any meaning, the first recommendation made in the PCAST Report is that “[p]olicy attention should focus more on the actual uses of big data and less on its collection and analysis.” PCAST Report, pp. 49-50.

[xxx] WH Report, p. 56.

[xxxi] WH Report, p. 24.

[xxxii] WH Report, p. 23.

[xxxiii] PCAST Report, p. 44.

[xxxiv] WH Report, p. 24.

[xxxv] PCAST Report, pp. 48-49.

[xxxvi] PCAST Report, p. 49.

[xxxvii] PCAST Report, pp. 49-50.

[xxxviii] It must be noted that many leading regulators and academics have a different view on the importance and role of notice and consent, and argue that these principles in fact deserve more focus. Seee.g.The Unintended Consequences of Privacy Paternalism, Ann Cavoukian, Ph.D., Dr. Alexander Dix, LLM, and Khaled El Emam, Ph.D. (2014), last found at http://www.privacybydesign.ca/content/uploads/2014/03/pbd-privacy_paternalism.pdf.