What changed in this filing

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Item 1. Business

2022-03-01 compared with 2021-02-26 · 82 added, 101 removed, 161 unchanged (53% of the section changed)

Fortive Corporation is a provider of essential technologies for connected workflow solutions across a range of attractive end-markets.

Our well-known brands hold leading positions in intelligent operating solutions, precision technologies, and advanced healthcare solutions.

Our businesses design, develop, service, manufacture, and market professional and engineered products, software, and services for a variety of end markets, building upon leading brand names, innovative technologies, and significant market positions.

Our research and development, manufacturing, sales, distribution, service, and administrative facilities are located in more than 50 countries across North America, Asia Pacific, Europe, and Latin America.

We are guided by our shared purpose to deliver essential technology for the people who accelerate progress, and we are united by our culture of continuous improvement and bias for action that embody the Fortive Business System (“FBS”).

Our strategic segments - Intelligent Operating Solutions, Precision Technologies, and Advanced Healthcare Solutions - include well-known brands with leading positions in their markets.

Our businesses design, develop, manufacture, and service professional and engineered products, software, and services, building upon leading brand names, innovative technologies, and significant market positions.

We are headquartered in Everett, Washington and employ a team of more than 18,000 research and development, manufacturing, sales, distribution, service, and administrative employees in more than 50 countries around the world.

We are guided by our shared purpose to deliver essential technology for the people who accelerate progress in buildings, factories, and hospitals, and we are united by our culture of continuous improvement and bias for action that embody the Fortive Business System (“FBS”).

Through rigorous application of the proprietary set of growth, lean, and leadership tools and processes that comprise FBS, we continuously improve business performance in the critical areas of innovation, product development and commercialization, global supply chain, sales and marketing, and leadership development.

Our commitment to FBS has enabled us to drive customer satisfaction and profitability, and generate significant improvements in innovation, growth, and core operating margins.

Additionally, FBS has enabled us to execute a disciplined acquisition strategy and expand our portfolio into new and attractive markets furthering our goal of creating long-term shareholder value.

On October 9, 2020, we completed the separation of our former Industrial Technologies segment (the “Separation”) by distributing 80.1% of the outstanding shares of Vontier Corporation (“Vontier”), the entity we created to hold the corresponding businesses, to Fortive stockholders on a pro rata basis.

To effect the Separation, the Company distributed to its stockholders two shares of Vontier common stock for every five shares of the Company’s common stock outstanding held on September 25, 2020, the record date for the distribution, with the Company retaining 19.9% of the shares of Vontier common stock immediately following the Separation (the “Retained Vontier Shares”).

On January 19, 2021, we completed an exchange of all

of the Retained Vontier Shares as part of a non-cash debt-for-equity exchange that reduced outstanding indebtedness of Fortive by $1.1 billion.

On October 1, 2018, we completed the split-off of businesses in our automation and specialty platform (excluding our Hengstler and Dynapar businesses) (the “A&S Business”) to our shareholders who elected to exchange shares of our common stock for all issued and outstanding shares of Stevens Holding Company, Inc.

(“Stevens”), the entity we incorporated to hold the A&S Business.

The split-off was immediately followed by the merger of Stevens with a subsidiary of Altra Industrial Motion Corp.

Concurrently with the split-off, we sold directly to Altra the remainder of the assets and liabilities of the A&S Business that were not otherwise contributed to Stevens.

Our commitment to FBS has enabled us to drive higher customer satisfaction and profitability, and generate significant improvements in innovation, growth, and core operating margins.

Additionally, our FBS tools have enabled us to execute a disciplined acquisition strategy and expand our portfolio into new and attractive markets, evolving to further our goal of creating long-term shareholder value.

On October 9, 2020, we completed the separation of Vontier Corporation (“Vontier”), the entity we created to hold our former Industrial Technologies segment (the “Separation”).

The accounting requirements for reporting the Vontier business as a discontinued operation were met when the Separation was completed.

Accordingly, the consolidated financial statements reflect the results of the Vontier business as a discontinued operation for all periods presented.

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Fortive Corporation is a Delaware corporation and was incorporated in 2015 in connection with the separation of Fortive from Danaher Corporation (“Danaher” or “Former Parent”) on July 2, 2016 as an independent, publicly-traded company, listed on the New York Stock Exchange.

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Reportable Segments

Before the Separation, we reported our results in two reportable segments consisting of Professional Instrumentation and Industrial Technologies.

In connection with the Separation, and in light of organizational and leadership changes we made to enhance and better evaluate the operational performance of and allocate resources to our businesses, we now operate and report our results in three segments, Intelligent Operating Solutions, Precision Technologies, and Advanced Healthcare Solutions, each of which is further described below.

We operate and report our results in three segments, Intelligent Operating Solutions, Precision Technologies, and Advanced Healthcare Solutions, each of which is further described below.

Intelligent Operating Solutions

Our Intelligent Operating Solutions segment provides leading solutions to accelerate industrial and facility reliability and performance, as well as compliance and safety across a range of vertical end markets, including manufacturing, process industries, healthcare, utilities and power, communications and electronics, among others.

The businesses in our Intelligent Operating Solutions segment provide a broad and differentiated offering of instrumentation, sensors, software, and services to address these critical workflows for our customers.

These offerings include connected reliability tools, environment, health, safety, and quality (EHSQ) enterprise software products, facility and asset lifecycle software, and pre-construction planning and construction procurement solutions.

We also offer a series of leading hardware offerings including ruggedized professional test tools, electric, pressure, and temperature calibration tools for high-end government and industrial labs, as well as portable gas detection tools which keep workers safe in industries where air quality and safety cannot be taken for granted.

Typical users of these offerings include electrical engineers, electricians, electronic technicians, EHSQ professionals, network technicians, facility managers, first-responders, and maintenance professionals.

Products and services within our Intelligent Operating Solutions segment are marketed under a variety of leading brands, including ACCRUENT, FLUKE, FLUKE NETWORKS, GORDIAN, INDUSTRIAL SCIENTIFIC, INTELEX, and PRUFTECHNIK.

Our Intelligent Operating Solutions segment provides leading workflow solutions to accelerate industrial and facility reliability and performance, as well as compliance and safety across a range of vertical end markets, including manufacturing, process industries, healthcare, utilities and power, communications and electronics, among others.

The businesses in our Intelligent Operating Solutions segment provide differentiated instrumentation and sensors, software and services to address our customers’ toughest workflow challenges.

These offerings include connected reliability tools, environment, health, and safety (EHS) enterprise software products, work order and service provider management database and software, facility and asset lifecycle software, and pre-construction planning and construction procurement solutions.

We offer a series of leading hardware offerings, including ruggedized handheld professional test tools, electric, pressure, and temperature calibration tools for high-end government and industrial labs, as well as portable gas detection tools which keep workers safe in industries where air quality and safety cannot be taken for granted.

Typical users of these offerings include electrical engineers, electricians, electronic technicians, EHS professionals, network technicians, facility managers, first-responders, and maintenance professionals.

Products and services within our Intelligent Operating Solutions segment are marketed under a variety of leading brands, including ACCRUENT, FLUKE, GORDIAN, INDUSTRIAL SCIENTIFIC, INTELEX, PRUFTECHNIK, and SERVICECHANNEL.

Precision Technologies

Our Precision Technologies segment supplies technologies to a broad set of vertical end markets, enabling our customers to accelerate the development of innovative products and solutions.

Our Precision Technologies segment supplies instrumentation and sensing technologies to a broad set of vertical end markets, enabling our customers to accelerate the development, manufacture and launch of innovative products and solutions.

We provide our customers with electrical test and measurement instruments and services, energetic material devices, and a broad portfolio of sensor and control system solutions.

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In our energetic materials business, we design, manufacture, and market highly-engineered energetic material solutions for commercial, defense, and space markets.

At Tektronix, we provide our customers with a broad portfolio of test and measurement instruments serving a variety of end markets including communication, consumer electronics, semiconductor, defense, automotive, and industrial.

Customers for these products and services include design engineers for advanced electronic devices and equipment, process and quality engineers focused on improved process capability and

productivity, facility maintenance managers driving increased uptime, and other customers for whom precise measurement, reliability, and compliance are critical in their applications.

At Tektronix, we provide our customers with a leading portfolio of test and measurement instruments serving a variety of end markets including communication, consumer electronics, semiconductor, defense, automotive, and industrial.

Customers for these products and services include design engineers for advanced electronic devices and equipment, process and quality engineers focused on improved process capability and productivity, facility maintenance managers driving increased uptime, and other customers for whom precise measurement, reliability, and compliance are critical in their applications.

Products and services in our Precision Technologies segment are marketed under a variety of brands, including ANDERSON-NEGELE, GEMS, SETRA, HENGSTLER-DYNAPAR, QUALITROL, PACIFIC SCIENTIFIC, KEITHLEY and TEKTRONIX.

Advanced Healthcare Solutions

Our Advanced Healthcare Solutions segment serves healthcare customers with enabling products and services for critical activities that help ensure safe, efficient, and timely healthcare.

Through the Advanced Healthcare Solutions segment, we provide broad hardware and software portfolio offerings optimized around our end-users’ most critical workflows, including instrument and device reprocessing, instrument tracking, cell therapy equipment design and manufacturing, biomedical test tools, radiation safety monitoring, and asset management.

Our Advanced Healthcare Solutions segment supplies critical workflow solutions to hospitals and other healthcare customers, enabling safer, more efficient, and higher quality healthcare.

Through the Advanced Healthcare Solutions segment, we provide hardware, consumables, software and services that optimize our customers’ most critical workflows, including instrument sterilization and device reprocessing, instrument tracking, cell therapy equipment design and manufacturing, biomedical test tools, radiation safety monitoring, end-to-end clinical productivity solutions and asset management.

Our offerings provide critical sterilization and disinfection solutions, including low-temperature hydrogen peroxide sterilization solutions and advanced infection prevention and patient safety in healthcare facilities.

In addition, we provide subscription-based surgical inventory management systems to healthcare facilities to facilitate inventory management and regulatory compliance as well as subscription-based technical, analytical, and compliance services to determine radiation exposure.

In addition, we provide subscription-based surgical inventory management systems to healthcare facilities to facilitate inventory management and regulatory compliance as well as

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subscription-based technical, analytical, and compliance services to determine radiation exposure.

We also serve gastroenterology and other clinical specialties with solutions that span the entire patient procedure, from pre-op through post-op recovery and follow-up, enhancing physician efficiency and effectiveness.

Furthermore, through our solutions and services, we enable developers and engineers in healthcare and other critical industries across the end-to-end product creation cycle from concepts to finished products.

Products and services in our Advanced Healthcare Solutions segment are marketed under a variety of brands, including ASP, CENSIS, CENSITRAC, EVOTECH, FLUKE BIOMEDICAL, INVETECH, LANDAUER, RAYSAFE, and STERRAD.

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The following discussion includes information common to all of our segments.

Our manufacturing operations employ a wide variety of raw materials, including electronic components, steel, plastics and other petroleum-based products, cast iron, aluminum, and copper.

Our manufacturing operations employ a wide variety of raw materials, including electronic components, steel, plastics and other petroleum-based products, aluminum, and copper.

Prices of oil and gas affect our costs for freight and utilities.

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Tariffs affect our costs for impacted materials or components we import into the United States.

No single supplier is material, although for some components that require particular specifications or qualifications there may be a single supplier or a limited number of suppliers that can readily provide such components.

Based on allocation of annual spend among our various suppliers, no single supplier is material.

However, some components that require particular specifications or qualifications are dependent on a single supplier or a limited number of suppliers that can readily provide such components.

We utilize a number of techniques to address potential disruption in and other risks relating to our supply chain, including in certain cases the use of safety stock, alternative materials, and qualification of multiple supply sources.

During 2020 we had no raw material shortages that had a material effect on our business.

While the COVID-19 pandemic and the widespread supply chain challenges due to labor, raw material, and component shortages, as well as widespread logistics issues had affected multiple industries and raised material and shipping costs, our supply chain was responsive to these dynamics, and we implemented solutions, including through FBS, to effectively support our near-term operations, and help countermeasure production material shortages and distribution limitations.

For a further discussion of risks related to the materials and components required for our operations, please refer to “Item 1A.

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Our management believes that we have a market leadership position in most of the markets we serve.

access, service and support, technology and innovation, breadth of product, service and software offerings, and brand name recognition.

Key competitive factors vary among our businesses and product and service lines, but include the specific factors noted above with respect to each particular business and typically also include price, quality, performance, delivery speed, applications expertise, distribution channel access, service and support, technology and innovation, breadth of product, service and software offerings, and brand name recognition.

For a discussion of risks related to competition, please refer to “Item 1A.

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General economic conditions impact our business and financial results, and certain of our businesses experience seasonal and other trends related to the industries and end markets that they serve.

For example, capital equipment sales are often stronger in the fourth calendar quarter and sales to OEMs are often stronger immediately preceding and following the launch of new products.

For example, sales of capital equipment and sterilization consumables are often stronger in the fourth calendar quarter and sales to OEMs are often stronger immediately preceding and following the launch of new products.

However, as a whole, we are not subject to material seasonality.

Human Capital Resources

Empowering our talented global team to contribute in meaningful ways is a critical component of our strategy and our success.

To support the advancement of our employees and the success of our Company, we invest in and develop our employees at every level.

We are committed to creating a challenging and collaborative culture and environment where our employees can grow, develop, and do their best work.

COVID-19 Response

In the uncertainty that immediately followed the COVID-19 pandemic, we were guided by five key pillars in our response to our employees:

Safety, Transparency, Empathy, Science and Employee Trust.

The policies we implemented were guided with the safety of our employees, their families, our customers, and our communities as the number one priority, with our actions informed by data and expert public health guidance.

The manner in which we considered and communicated our policies and actions were driven by the recognition of, and empathy for, the uncertainty, fear, and real-life impact caused by the pandemic for our colleagues.

With that in mind, we focused on being agile and transparent with what we were doing and why we were doing it, while listening to ongoing feedback from our global teams and quickly making changes where needed.

We did our best to accommodate the needs of our people as they managed through an incredibly difficult year personally and professionally.

Driven by our values, we:

• Formed global and local response teams at every level to create hundreds of standard processes to share best practices and streamline communication to keep our employees safe and informed;

• Acted quickly to limit and then stop business travel;

• Ensured pay continuity for quarantine periods for our employees;

• Quickly made the decision to enable and then mandate remote work for those who were able to do so while ensuring that our essential manufacturing team members had the education, resources, and support needed to stay safe on the job;

• Created flexible shifts and schedules to accommodate childcare and other family or personal needs;

• Provided subsidized childcare and other caregiver services as well as parental counseling;

• Waived deductibles, co-pays, and co-insurance for COVID-19 testing or treatment as well as all virtual healthcare visits;

• Provided enhanced counseling and mental health coverage and services.

Employee Profile and Development

As of December 31, 2020, we employed approximately 17,000 persons, of whom approximately 9,500 were employed in the United States and approximately 7,500 were employed outside of the United States.

Outside the United States, we have government-mandated collective bargaining arrangements and union contracts in certain countries, particularly in Europe where certain of our employees are represented by unions and/or works councils.

Human Capital Strategy

Our Human Capital Strategy is designed to attract, retain, and develop the best talent to drive our business strategy forward by offering a competitive reward structure and a compelling employee value proposition.

A key element of our value proposition is our commitment to our employees’ continued learning, development, and success.

To respond to our growing business and technology changes, our Leadership, Development & Learning team has adopted a blended learning approach that combines online digital learning with classroom teaching and coaching to effectively scale continuous learning and accelerate our ability to learn quickly and remain agile throughout Fortive.

With the challenges presented by the COVID-19 pandemic, we further enhanced our virtual and online learning and development platform to ensure safety of our employees without compromising our commitment to our employees’ ongoing career success.

The following is a summary of some of the key support we provide to our employees to further their learning and development:

The Fortive9 is our leadership framework that is critical to how we guide the development of our employees because Fortive9 is how we aspire to work, deliver value, and build organization capability.

Examples of the Fortive 9 include Customer Obsessed, Innovation, and Team and Talent Development.

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Human Capital Management

Building a strong culture and employer brand is critical to activating our shared purpose through our approximately18,000 employees around the world.

We are focused on attracting, retaining, and developing the world’s best talent to drive our business strategy.

We do this by offering challenging career opportunities that enable growth and an inclusive, winning culture strengthen by high expectations.

Empowering our talented, global team to contribute in meaningful ways drives our success and builds the organization for the future.

To realize our promise to make a difference for our customers, teams and the world around us, we are accelerating our work to strengthen our inclusion, diversity, and equity through deliberate action and transparency about our progress.

Growth and Development

To support our teams’ learning and advancement and our company’s success, we invest in our people at every level.

We are committed to creating a challenging and collaborative culture and an environment in which our employees can grow, develop, and do their best work.

We provide numerous, valuable growth and development opportunities for our employees through experiences such as:

The Fortive9 is our leadership behavior framework that guides the development of our employees.

It is a roadmap for the way we aspire to work, deliver value, and build strong teams.

Examples of the Fortive9 include Deliver Results, Customer Obsessed, Innovate for Impact, and Adaptability.

People Leader Experience

Comprehensive learning for both new and experienced leaders, harnessing the best of interactive learning, and providing the critical tools as our employees assume greater people leadership responsibilities throughout their career with us.

Deep, experiential learning for both new and experienced leaders, harnessing the best of interactive learning, and providing critical tools as our employees assume greater people leadership responsibilities.

Accelerated Leadership Experience (ALE)

Designed for high performing employees as preparation for running Fortive businesses or functions.

We use immersive, experiential learning, where individuals can drive personal progress and overcome obstacles to fulfill their leadership potential.

Designed for high performing employees in preparation for leading Fortive businesses or functions.

We use immersive and experiential learning, where leaders develop personal skill and insight to fulfill their potential.

FBS Office and University

FBS Office is dedicated to strategically imbed FBS in everything we do, from innovations to operations.

FBS University, our proprietary virtual and hands-on learning environment, develops and reinforces learning for hundreds of FBS Champions across our Company each year to deliver value.

An immersive development experience that leverages the diversity of our operating companies.

Supported with intensive development in the FBS toolset, active mentoring from the FBS Office, and executive career coaching, participants advance their FBS expertise and business acumen.

The Fortive Business System Office is dedicated to strategically embedding the mindset and toolset in everything we do.

FBS University, our proprietary virtual and hands-on learning environment, develops and reinforces learning for hundreds of FBS Champions across our company each year to deliver value for our customers and shareholders.

Supported with intensive development in the FBS toolset, active mentoring from the FBS Office, and executive career coaching, participants advance and share their expertise across different businesses.

Growth Accelerator

A key development experience that enables our team to solve challenges in new, inspiring ways through three key innovation tools, Deep Customer Insight, Solution Generation, and Experimentation, each designed to enable our employees to develop critical solutions for customers.

Each one of these investments in our team delivers value to both our people and our customers, with the investments focused on development that adds most value to stakeholders.

A key development experience that enables our team to solve challenges in new, inspiring ways through three key innovation tools:

Deep Customer Insight, Solution Generation, and Experimentation -- each designed to enable our employees to develop critical, breakthrough solutions for customers.

Each one of these investments in our team delivers value to both our people and our customers.

Inclusion and Diversity

We believe that creating inclusive places to work and diverse points of view are the lifeblood of innovation and growth and provide us with a strategic advantage.

In 2020, we continued to make significant strides to reflect the needs, priorities, and experiences of our global team and strengthen our culture of inclusion and diversity.

Creating inclusive places to work and promoting diverse points of view are the lifeblood of our success.

In the spirit of continuous improvement, we continued to make significant strides in 2021 to reflect the priorities, and experiences of our global team and strengthen our culture of inclusion.

Our Board of Directors and our Compensation Committee oversee our Human Capital Management strategies, including our inclusion and diversity efforts.

Our VP, Inclusion & Diversity works closely with our senior management and our Inclusion & Diversity Council, involving employees at every level in establishing a collaborative vision that will truly reflect the needs, priorities, and viewpoints of our diverse global team.

Our inclusion and diversity strategies are founded on the following pillars, using the insights from employees, community, and other stakeholders:

Our VP, Inclusion & Diversity works closely with our senior management and our Inclusion & Diversity Council, involving employees at every level in advancing our work to build and nurture and strong and diverse global team.

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Strategic Pillar

Inclusion and Diversity Matters:

Build a diverse Fortive through hiring, developing, and retaining a strong team

Build a diverse Fortive through hiring, developing, and retaining a strong and diverse team

Everyone Owns Inclusion:

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I&D in Our DNA:

Build a culture of equity that enables greater innovation for customers and the world

Please refer to our Proxy Statement for more details about our progress against these pillars.

Engagement and Communication

A key focus of our human capital management strategy is active listening and effective communication throughout the organization.

Our senior leaders are committed to actively listen to our employees and other stakeholders, as demonstrated by over one hundred separate “Courageous Conversations” held in 2020 to actively listen and learn on race and social justice matters so we can make a real impact with our actions.

In addition, in 2020, we conducted several employee surveys focused on getting feedback on actions related to our COVID-19 response work.

We wanted to ensure our teams had the best support possible through such an extremely challenging time.

This allowed for us to listen, learn, and adjust quickly to the needs of our teams across the globe.

Based on the learnings from 2020, we have adjusted our approach to employee experience surveys and feedback.

Beginning in 2021, we have moved from an annual survey to shorter quarterly employee experience surveys and a more thorough biennial survey.

This will enable us to be more responsive to the needs and feedback from the organization while enhancing our ability to understand trends over time.

The results inform both management and the Board of Directors on appropriate actions and strategies to continuously enhance our employees’ experience.

Build a culture of equity that enables greater innovation and performance for customers and the world

In 2021, we continued to strengthen our culture of inclusion and diversity by introducing a new development experience, providing our leaders tools and support to become more inclusive leaders.

We also expanded our employee resource communities, and operationalized equitable talent processes.

Reinforcing our I&D priorities, annual I&D goals are imbedded into performance measures for both executives and other senior leader roles across Fortive.

Employee Experience and Communication

A key focus of our human capital management strategy is creating exceptional employee experiences through active listening and communication throughout the organization.

Our senior leaders are committed to actively searching out and listening to our employees and other stakeholders to build our culture.

As part of this effort, we have continued to conduct our annual employee experience survey, but also, beginning in 2021, we moved to a shorter feedback loop, introducing quarterly pulse surveys.

This cadence has enabled us to be more responsive to feedback while enhancing our ability to understand trends over time.

With over 80% of our team participating throughout 2021, our overall employee engagement score averaged 77%, and our inclusion and belonging score averaged 81%.

As in prior years, the 2021 results informed both management and the Board of Directors on appropriate actions to continuously enhance our employees’ experience.

Government Contracts

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After a device has received 510(k) clearance for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design, materials, method of manufacture, or intended use, may require a new 510(k) clearance and payment of an FDA user fee.

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Market access, sales, and marketing of medical devices in non-U.S.

countries are subject to foreign regulatory requirements that vary widely from country to country.

For example in the European Economic Area (“EEA”), a medical device must meet the Medical Devices Directive’s (“MDD”) Essential Requirements or, effective May 26, 2021, the Medical Devices Regulation’s (“MDR”) General Safety and Performance Requirements.

For example in the European Economic Area (“EEA”), a medical device must meet the Medical Devices Directive’s (“MDD”) Essential Requirements or, for new devices placed on the market after May 26, 2021, the Medical Devices Regulation’s (“MDR”) General Safety and Performance Requirements as well as other requirements set out in the MDD/MDR, depending on the device’s risk class.

Before placing a medical device on the EEA market, the manufacturer must prepare a declaration of conformity, certifying that the device complies with the MDD/MDR, and must then affix the CE mark.

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For access to the UK market, manufacturers must obtain a UKCA Certificate and affix a UKCA mark to their medical devices.

However, the CE mark will be accepted in the UK until July 1, 2023.

However, the EEA’s CE mark will be accepted in the UK until July 1, 2023.

Any medical devices we manufacture and distribute are subject to pervasive and continuing regulation by the FDA and certain state and certain other comparable foreign authorities.

As a medical device manufacturer, our manufacturing facilities are subject to inspection on a routine basis by the FDA and other comparable foreign authorities as well as audits by our notified body.

We are required to adhere to the Current Good Manufacturing Practices requirements, as set forth in the Quality Systems Regulation, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all phases of the design and manufacturing process.

We are required to adhere to the Current Good Manufacturing Practices requirements, as set forth in the Quality Systems Regulation, as well as other applicable standards which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all phases of the design and manufacturing process.

We must also comply with global post-market surveillance regulations, including adverse event reporting requirements, which require that we review and report to the FDA and other comparable foreign authorities any incident in which our products may have caused or contributed to a death or serious injury.

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federal government.

The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false

claim to the federal government, and to share in any monetary recovery.

In addition, the government may assert that a claim including items and services resulting from a violation of the U.S.

The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery.

In addition, the government may assert that a claim

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including items and services resulting from a violation of the U.S.

Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.

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As a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal, and/or sensitive data in the course of our business.

For example, in the United States, HIPAA privacy and security rules require certain of our operations to maintain controls to protect the availability and confidentiality of patient health information, individual states regulate data breach and security requirements, and multiple governmental bodies assert authority over aspects of the protection of personal privacy.

Data privacy and security laws are rapidly evolving.

In particular, a new, broad privacy law in California, the California Consumer Privacy Act (“CCPA”), came into effect in January 2020.

In particular, a broad privacy law in California, the California Consumer Privacy Act (“CCPA”), came into effect in January 2020.

The CCPA has some of the same features as the GDPR (discussed below), and has already prompted several other states to consider similar legislation.

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In these countries and elsewhere, the laws applicable to data privacy and security may require changes to business practices or additional investment for compliance purposes.

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Environmental Laws and Regulations

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business